EU

• Notified Bodies
  • TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true
  • AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1
• MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf
  • Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK
• MDCG 2024-5 Guidance – SInvestigator’s Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf
  • Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx
•  Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=

•  Team-NB: ESMINT initiative –  Call for expert: https://www.team-nb.org/esmint-initiative/
•  Spain AEMPS Bulletin on Health Products –  From Jan – March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan
•  Germany: Classification – Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html
•  Swiss: SaMD –  information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf
• Turkey: 26 May 2024 –  Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706

Article to read

• European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf

Training

• Training EU MDR –  Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/
•  Malaysia training –  Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI
• Team-NB training  –  IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/

Events

•  Events –  Check Medtech Conf: https://MedtechConf.com

Rest of the world

•  South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do
•  South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)
•  South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1

 Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0

•  Australia: Consultation on IFU –  Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats

Podcast

•  Radiation Sterilisation Master File   –  Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/
•  What is the impact of AI Act on Medical Devices –  Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/
•  Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/

The post Medical Device NewsMAY 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it with your team. 

Who is Lesley Worthington? 

Lesley works with individuals and teams to fine-tune their Quality conversations, initiatives, and internal communications to create a better understanding of the role and concepts of quality assurance throughout their organization. 

Through her leadership and executive coaching, she supports professionals as they work on improving their relationships and effectiveness in their roles allowing them to achieve their fullest potential, professionally, and empowering them to move their organizations toward a robust Quality Culture. 

She runs a community, The Quality Network, which supports Quality professionals as they work on the skills that allow them to build a Quality Culture. The Quality Network is a place for learning, coaching, support, and networking and includes webinars, resources, a member platform, courses, and office hours.  

She combines 20 years of quality and regulatory experience in medical devices, in Canada, with thousands of hours of teaching and coaching to provide her clients with the skills, techniques, insights, and mindset that raise their confidence, take their communication skills to the next level, and allow them to have a positive impact in their organizations. 

She’s got a Psychology Degree, a Law Degree, English as a Second Language Teaching Qualifications, and is a Certified Executive Coach. 

Who is Monir El Azzouzi? 

Monir El Azzouzi, a distinguished expert in the medical device sector, holds a Biomedical Engineering degree from ISIFC in France. With extensive experience at top-tier companies such as Bausch+Lomb, Aesculap, and Johnson & Johnson, Monir has a deep understanding of the industry’s challenges and opportunities. His commitment to enhancing industry standards and support led him to establish Easy Medical Device. 

Easy Medical Device is an innovative company dedicated to enriching the medical device community through educational outreach such as podcasting, blogging, and video creation. The company also offers specialized training programs, notably the Green Belt Certificate for EU MDR, to elevate professional skills within the industry. 

Beyond education, Easy Medical Device provides comprehensive consulting services, helping manufacturers navigate the complexities of CE Marking, FDA registration, clinical evaluation reports, internal audits, design and development, supplier reviews, eQMS implementation, and due diligence. Our expertise extends to acting as authorized representatives and importers in Europe, Switzerland, and the UK, facilitating smoother market entry for our clients. 

Monir’s vision for Easy Medical Device is to establish it as the definitive one-stop shop for all services related to medical device manufacturers. We are committed to assisting you in introducing and advancing your projects with efficiency and compliance. 

Do not hesitate to contact Monir El Azzouzi at Easy Medical Device to explore how we can support your medical device initiatives. 

Links

• LinkedIn: https://www.linkedin.com/in/lesleyworthington/ 
• Website: https://lesleyworthington.com/  
• Email: [email protected]  

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Why and how to build a Quality Culture? appeared first on Medical Device made Easy Podcast. hamza benafqir

The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities.  

Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device community. 

Who is Erik Vollebregt? 

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ 
• Axon Lawyers Website: https://www.axonlawyers.com/ 
• Erik Blog: https://medicaldeviceslegal.com/ 

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post What is the impact of AI Act on Medical Devices?  appeared first on Medical Device made Easy Podcast. hamza benafqir

If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant. 

Who is Adam Isaacs Rae? 

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

• Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/ 
• ISO 11137- Radiation standards : https://www.iso.org/standard/33952.html 
• ISO 11607 – Packaging of terminally sterilised products: https://www.iso.org/standard/70799.html 
• ISO 11737 – Bioburden: https://www.iso.org/standard/66451.html 

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Radiation Sterilisation Master File (ISO 11137 & 11607)  appeared first on Medical Device made Easy Podcast. hamza benafqir

Sponsor:

Medboard: https://www.medboard.com/

EU

• MDR and IVDR national languages update – France accepts English
  • MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf
  • IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf
• Which devices for Expert Panel – Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf
  • 94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products
  • On Class III implantable – Top is with Active Implantable Devices
  • Exempt devices are mainly within 3 categories (Main reason: Modification of a device already marketed):
    • Vascular and cardiac prostheses
    • Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligaments synthesis
    • Implantable prosthetic and osteosynthesis devices
• Annex XVI: Is Brain Stimulation device risk? –  SCHEER should evaluate by End 2025: https://health.ec.europa.eu/document/download/e6de1e88-2821-48f6-98f9-a56ea61cbfad_en?filename=scheer_q_031.pdf
  • SCHEER = Scientific Committee on Health, Environmental and Emerging Risks
• SCHEER on Phtalate – Update of the guidelines: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-update-scheer-guidelines-benefit-risk-assessment-presence_en
  • Consultation until April 28th, 2024
• MDCG subgroup Agenda – What is coming?: https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf
• MDCG 2024-3 on CIP – Clinical Investigation: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en.pdf
• New Notified Body RISE Sweden – Welcome to the team 3033: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=d37c034bc695d2e143b5145b4cb7cd73caf8983c&group=NOTIFICATION&download=true
  • 44 MDR NB
  • 12 IVDR NB

UK

• MHRA: Electrical Devices in Clinical Trials – Advice on application with separate document: https://assets.publishing.service.gov.uk/media/65fb0d66aa9b76001dfbdc28/MHRA_Electrical_Guidance_for_Clinical_Investigations_Modified_12_Feb.pdf

Ireland

• HPRA Newsletter- IVD, Eudamed, Custom-made, Clinical trials: https://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-medical-devices-newsletter-issue-57-february-2024.pdf

Turkey

• Reminder on MDR transition period – May 26th, 2024: https://titck.gov.tr/storage/Archive/2024/announcement/duyurumetni_67231ed0-2553-4708-8231-7951c767e066.pdf
  • Turkey strongly inform the different parties regarding MDR transition

Events

• RAPS Euro Convergence – May 6-8 in Berlin-Germany: https://www.raps.org/europe-2024/home
• Medtech Conf Map: https://medtechconf.com/event/connect-with-european-andinternational-regulatoryaffairs-peers-in-berlin-2/

Services

• Packaging for Medical and Pharmaceutical – Design, Manufacturing and delivery: https://easymedicaldevice.com/packaging-for-medical-devices/

ROW

USA

• Ban devices – Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans
  • CNN article: https://edition.cnn.com/2024/03/25/health/fda-ban-electrical-stimulation-devices/index.html
  • Comments open until May 28, 2024: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-proposes-new-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior
  • Bans
    • Prosthetic Hair Fibers since 1983
    • Powdered Surgeon’s Gloves since 2017
    • Electrical Stimulation Devices for Self-injurious or Aggressive Behavior since March 2024
• Animal Studie for Dental Bone Grafting devices – Choose the right animal Model: https://www.fda.gov/media/177340/download
  • Minimum of 3 animals
  • Animal Model: Canine and Porcine model instead of rodents
• FDA: Deviations on Neuralink lab – Animal Study good practices: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/
  • Calibration of equipment’s are not done
  • Quality officials not signing documents

Australia

• Vigilance Reporting in Australia – For Recall and non-Recall: https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf
  • Recall action Template: https://www.tga.gov.au/resources/resource/forms/recall-action-templates

Saudi Arabia

• Guidance on Surgical Sutures – This contains some cheat code: https://www.sfda.gov.sa/sites/default/files/2024-03/%28MDS-G021%29En.pdf
  • Endpoints that should be addressed
  • Laboratories should be ISO/IEC 17025
  • Shelf life should follow ASTM F1980

Brazil

• MOU between Brazil and Paraguay – Memorandum of Understanding: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-e-agencia-reguladora-do-paraguai-assinam-primeiro-memorando-de-entendimento
  • Bilateral cooperation on health surveillance
  • Strenghtening regulatory capacity
• GMP validity from two to four years – If certified through MDSAP: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-amplia-para-quatro-anos-prazo-de-validade-do-certificado-de-boas-praticas-de-fabricacao
• Prioritize registration of Dengue Diagnosis Devices – Submit Now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-prioriza-registro-de-dispositivos-para-diagnostico-da-dengue
  • Combat dengue epidemic as a matter of urgency

India

• CDSCO: PSUR through online portal – From April 1st, 2024: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwMTI=
  • Online portal: https://www.cdscomdonline.gov.in/NewMedDev/Homepage

Malaysia

• Malaysia Faster approval – Establishment license application: https://www.mda.gov.my/index.php/announcement/1377-faster-approval-for-establishment-license-application-complete-applications-processed-within-14-21-working-days
  • 14 to 21 Working days from date of application
  • List of documents within the link

China

• China Guidelines on registration – Specific products: https://www.cmde.org.cn/xwdt/zxyw/20240318133300123.html
  • Corneal Topograph
  • Laparoscopic surgery system
  • Optical Radiation Safety device
  • Monkeypox virus nucleid acid detections agent: https://www.cmde.org.cn/xwdt/zxyw/20240318111545184.html

Podcast

• Podcast Nostalgia
  • Episode 275 – FDA aligns QMSR with ISO 13485 (Naveen Agarwal): https://podcast.easymedicaldevice.com/275-2/
  • Episode 276 – How to do Postmarketing Surveillance to right way? (Steve Curran): https://podcast.easymedicaldevice.com/276-2/
  • Episode 277 – How to benefit from Survey to build Clinical Evidence? (Cesare Magri): https://podcast.easymedicaldevice.com/277-2/

Easy Medical Device

• [email protected]

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News April 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field. 

Who is Cesare Magri? 

Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

• Linkedin Post High Quality Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-clinicalinvestigation-activity-7173590917466042368-cFdG/ 
• Linkedin Post User Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-survey-activity-7175785619837595648-aRxY 

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post How to benefit from Surveys to build Clinical Evidence? appeared first on Medical Device made Easy Podcast. hamza benafqir

The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified. 

Who is Steve Curran? 

Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market.  He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

• Steve’s LinkedIn: https://www.linkedin.com/in/stephencurran/ 
• Blog on PMS: https://www.trinzo.com/medical-device-pms 
• PMS Training: https://www.meddevsolutions.co.uk/course/pms-training 
• Trinzo Website: www.trinzo.com 
• Trinzo LinkedIn: https://www.linkedin.com/company/trinzo  

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post How to do Postmarketing Surveillance the right way?  appeared first on Medical Device made Easy Podcast. hamza benafqir

The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution? 

Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR. 

Who is Naveen Agarwal? 

Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

• Naveen Agarwal Linkedin Profile: https://www.linkedin.com/in/naveenagarwal/ 
• Learn more about Let’s Talk Risk! here ans subscribe: https://naveenagarwalphd.substack.com/about 
• Webinar recording – Getting Ready for QMSR: https://naveenagarwalphd.substack.com/p/webinar-5-getting-ready-for-qmsr  
• Risk management training on ACHIEVE: https://www.achievexl.com/ 
•  

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Learn more about FDA QMSR alignment with ISO 13485 appeared first on Medical Device made Easy Podcast. hamza benafqir

EU

• EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/
• Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf

• Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/
• EURL Second Call – More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en
• TEAM-NB Position Paper – Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/03/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf
• EMDN Proposal – Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/
  • MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf
• Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf

Training

• Training Green Belt EU MDR – Learn by practicing: https://school.easymedicaldevice.com/course/gb30
  • Open March 25th, 2024 until March 29th, 2024
• TEAM-NB Training – Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdf
  • April 29th, 2024

Services

• Packaging and IFU – Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/

ROW

USA

• Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device

CANADA

• Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html
  • Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html

Mexico

• Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es

Saudi Arabia

•  SFDA Harmonized Standards – Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf

Qatar

•  Qatar Telemedicine – Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf

Australia

• TGA SOPP requirements – System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf
• TGA Essential Principles – Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf
• Transition to EU MDR cases – Evidence of transition, DCR, Non-Compliance, Recalls:
  • https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf  
  • https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf
  • https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf
  • https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf

PODCAST

• Episode 271 – How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/
• Episode 272 – Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/
• Episode 272 – New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/

EASY MEDICAL DEVICE Services:

• Training: https://school.easymedicaldevice.com/emd-course/
• Authorized Representative EU: https://easymedicaldevice.com/eu-rep/
• Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/
• Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/
• Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/
• Eqms SmartEye; https://smart-eye.io
• Conferences: https://medtechconf.com/

The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a proposal for now. 

Who is Erik Vollebregt? 

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ 
• Axon Lawyers Website: https://www.axonlawyers.com/ 
• Erik Blog: https://medicaldeviceslegal.com/ 
• Linkedin post: https://www.linkedin.com/posts/erikvollebregt_medical-devices-council-endorses-new-measures-activity-7166021646573641730-abCh 
• Medical Devices: Council endorses new measures to help prevent shortage: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/?utm_source=dsms-auto&utm_medium=email&utm_campaign=Medical+devices%3a+Council+endorses+new+measures+to+help+prevent+shortages 
• Proposal text: https://data.consilium.europa.eu/doc/document/ST-6156-2024-INIT/en/pdf 

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post New EU Proposal – EUDAMED, IVDR & Shortage appeared first on Medical Device made Easy Podcast. hamza benafqir

When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a potential change that will happen and we want to alert you about that. 

Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode. 

Who is Christina Ziegenberg? 

 Dr. Christina Ziegenberg can look back on a distinguished career in medical technology, the chemical industry and pharmacy. With an education at the HBLVA for Chemical Industry in Vienna, a diploma in pharmacy at the University of Vienna and a doctorate at the Private University of Liechtenstein (UFL), she has held management positions at Hilti Aktiengesellschaft, the Liechtenstein State Administration and most recently at BVMed, where she holds the position of Deputy Managing Director / Head of the Regulatory Affairs Department.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

• BVMed website: www.bvmed.de 
• BVMed link: https://www.bvmed.de/de/english/bvmed-services?pk_campaign=tsr_CHK&pk_kwd=english_tsr-aktuelles-gT_mi_bvmed-services  
• Current BVMed Position Paper in German: https://www.bvmed.de/download/positionspapier-ethylenoxid  
• BVMed Position Paper with regards to the public consultation: https://www.bvmed.de/download/bvmed-positionspapier-ethylenoxid-einstufung-nach-biozidverordnung-bpr  
• Information regarding EtO from ECHA: https://echa.europa.eu/de/information-on-chemicals/biocidal-active-substances/-/disas/factsheet/1304/PT02 
• Assessment report: https://echa.europa.eu/documents/10162/3e7d946a-6939-2f2e-252e-dcd03d9ea36e  
• BPC Opinion: https://echa.europa.eu/documents/10162/5a3831c0-e6d4-7140-1e1b-2c8e3369edd4 

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Will EtO gaz become a Medical Device?  appeared first on Medical Device made Easy Podcast. hamza benafqir