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Medical Device made Easy Podcast
Monir El Azzouzi
On the Medical Device made Easy Podcast you'll learn how to place a compliant medical device on the Market. I will share with you my experience and one of my guests with also a lot of resources to download. I am Monir El Azzouzi a Medical Device Expert specialized in Quality and Regulatory Affairs. I am also the founder of the Medical Device blog Easy Medical Device where I try to teach to people the basics of Medical Devices. One of my Motto is "Would I give this product to a Member of my family" and I try to share this philosophy on all my platforms. If you are trying to learn more or to change your career to enter the medical device world, you should be part of my community. I will be your guide and will help you reach your objectives. The Regulation changes all over the world are hitting medical device manufacturers and they need you to help them be on track to come and learn with us.
- Is FMEA bad for your Risk Management?
In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree.
Who is Rod Beuzeval?
Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices.
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
- Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance
- Leap Compliance website: www.leapcompliance.com
- ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019
- Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U
- Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/
- eQMS for Risk Management: https://eqms-smarteye.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 Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast. hamza benafqir
14 November 2024, 12:00 am - How MDR and IVDR code can save you money?
In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice.
Who is Stefan Bolleininger?
Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
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
- Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
- BeOnQuality Website: https://www.be-on-quality.com/
- MDCG 2019-14 – MDR code: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf
- MDCG 2021-14 – IVDR code: https://health.ec.europa.eu/system/files/2021-07/md_mdcg_2021-14-guidance-ivdr-codes_en_0.pdf
- EMDN Code: https://webgate.ec.europa.eu/dyna2/emdn/
- Notified Body database NANDO : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation
- eQMS for Medical Devices: https://eqms-smarteye.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 How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast. hamza benafqir
7 November 2024, 12:00 am - Medical Device News November 2024 Regulatory Update
Medboard
EU
- Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf
- HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf
- EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793
- MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf
- Notified Bodies Overview – How many still remaining: https://health.ec.europa.eu/do cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf
- New MDR NEOEMKI in Bulgaria: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=0e4e49a1afef458542254b3556a5e83d85321b23&group=NOTIFICATION&download=true
- HPRA Notification for In-house Manufacturers – Frequently Asked Questions: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0053-faq-on-notification-for-in-house-manufacturers-of-medical-devices-and-in-vitro-diagnostic-medical-devices-v1.pdf?sfvrsn=8
- Harmonized Standards Summary List – For MDR and IVDR:
- MDCG 2024-11 – Qualification of IVDR: https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf
- PMS is not implemented correctly – IGJ report is shocking: https://english.igj.nl/binaries/igj-en/documenten/publication/2024/10/08/call-to-medical-device-manufacturers-implement-an-effective-pms-system/20241003_Call+to+medical+device+manufacturers+implement+effective+PMS+system.pdf
- EUDAMED in Turkey – Message: You should use it: https://titck.gov.tr/duyuru/tcokka-tibbi-cihazlara-iliskin-avrupa-veri-tabani-hakkinda-teblig-taslagina-iliskin-duyuru-11102024094328
- Turkey registration limited – 10 per individual: https://titck.gov.tr/duyuru/tibbi-cihaz-belge-ve-urun-kaydi-yapan-firma-ve-kullanicilarina-iliskin-duyuru-07102024151251
- UK Post-Market Surveillance – New amendment: https://www.legislation.gov.uk/ukdsi/2024/9780348264593/data.pdf
Training
- Team-NB training on Technical Documentation- November 6th: https://www.team-nb.org/wp-content/uploads/2024/07/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf
Events
MedtechConf events – Check the MAP
- Afrisummit 2024 in Cairo November 3 to 6: https://medtechconf.com/event/afrisummit/
- MEDxD 2024 In Berlin November 7th: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
- Medica 2024 in Dusseldorf November 11th: https://medtechconf.com/event/medica-2024/
ROW
Australia
- What is a Personalized Medical Device? – In Australia: https://www.tga.gov.au/sites/default/files/2024-10/understanding-personalised-medical-devices%20rules-including-3d-printed%20devices.pdf
- How to submit a notification on custom-made device in Australia: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
Mexico
GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0
South Africa
- South Africa and Australia MoU – Harmonization is on the way: https://www.sahpra.org.za/news-and-updates/south-african-and-australian-health-product-regulators-to-share-regulatory-information-and-expertise/
PODCAST
Podcast Nostalgia – Let’s review
- Episode 306 – What are the TOP 3 issues on CAPA with Georg Digel: https://podcast.easymedicaldevice.com/306-2/
- Episode 307 – What does a strategy for Regulatory Compliance Look like? https://podcast.easymedicaldevice.com/307-2/
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 November 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
31 October 2024, 12:00 am - What does a strategy for regulatory compliance looks like?
In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together.
Who is Adam Isaacs Rar?
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 a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- ■ Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/
- ■ Webpage The Other Consultants: theotherconsultants.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 does a strategy for regulatory compliance looks like? appeared first on Medical Device made Easy Podcast. hamza benafqir
24 October 2024, 12:00 am - What are the TOP 3 issues on CAPAs?
in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team.
Who is Georg Digel?
I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almost every mistake there is …Some of my “favorites”:
– Initiating CAPA without gathering facts
– Setting up KPIs but not monitoring them
– Confusing Correction with Corrective ActionTo be honest – I’ve made many of these mistakes myself.
Luckily, I learned and improved. Over time, I even took on bigger responsibilities. Some projects which I really enjoyed:
– Process harmonizations for 60 sites
– Setup of training programs for 1.000+ people
– KPI dashboard implementations for 813 CAPAsMy learnings were paired with painful experiences. I want to save you from all of them. My goal is to help you:
1. Avoid CAPA related audit findings or 483s
2. Implement meaningful metrics for your CAPAs
3. Train your people so they close records effectivelyWho 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
- Georg Digel LinkedIn: https://www.linkedin.com/in/georgdigel/
- Vincent Cafiso Podcast episode: Are you More Corrections or Corrective Actions or Preventive actions? https://www.youtube.com/watch?v=YsXfBv_AdWc
- How to be the best at CAPAs with Karandeep Badwal: https://www.youtube.com/watch?v=zWK1U7d2awY
- Most important issues on CAPAs: https://www.youtube.com/watch?v=lR4r14V5oHA
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 are the TOP 3 issues on CAPAs? appeared first on Medical Device made Easy Podcast. hamza benafqir
17 October 2024, 12:00 am - Medical Device News, October 2024 Regulatory Update
Medboard: https://www.medboard.com/
EUROPE
- TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf
- TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf
- MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf
- Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html
- Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html
- UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/
EVENTS
- TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/
- Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/
- MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/
NB
- ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3
ROW
Middle East
- Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf
Northern America
- USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory
- USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions:
- Air powered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based
- Dental Cements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway
- Dental Ceramics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway
- Dental Impressions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway
- Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html
South America:
- Brazil bans – Thermometers and Sphygmomanometers with a Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c
PODCAST
- Podcast Nostalgia – Last podcast to listen to-
- Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/
- Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/
- Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/
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, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
10 October 2024, 12:00 am - How to select the best plastic for your Medical Device?
In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this.
Who is Lucas Pianegonda?
Lucas Pianegonda is an expert for medical grade plastics, material testing and material compliance. He has experience as a material expert in ISO 13485 certified companies of several years, he knows the requirements the MDR makes towards medical devices and can translate these into material requirements. He has lead multiple projects on an international level successfully for topics like material change-overs, IP, bio compatibility and second source material qualification.
He is a self driven, communicative and assertive person, he loves challenges and he strives always for self improvement.
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
- Lucas Pianegonda LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/?locale=en_US
- Gradical website: https://gradical.ch/
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 select the best plastic for your Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir
3 October 2024, 12:00 am - UK vs EU vs US – How to switch to another region easily?
In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US.
Who is Claire Dyson?
Who is Claire Dyson?
Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS’s application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS’s international team developing accessible content to support manufacturers with the regulatory pathways and transitions.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/
- DQS website: https://www.dqsglobal.com/gb-en/
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
- Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
The post UK vs EU vs US – How to switch to another region easily? appeared first on Medical Device made Easy Podcast. hamza benafqir
24 September 2024, 12:00 am - How to do a PMCF Literature Search for Medical Devices?
In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right.
Who is Cesare Magri?
Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diagnostic manufacturers by leveraging clinical and non-clinical data for certification and marketing purposes. He has contributed to more than 100 clinical and performance evaluation for devices of all risk classes.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri/
- 4BetterDevices website: https://4betterdevices.com/
- Evidence link: https://evidence.systems
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 a PMCF Literature Search for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
17 September 2024, 12:51 am - Medical Device News, Septembre 2024 Regulatory Update
EU
- e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN
- MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf
- Implementing Act IVDR Common specifiaction – Consultation until Sept 16th: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14383-In-vitro-diagnostic-medical-devices-common-specifications_en
- Cyber Security in Health and medicine – Results from Cyber incidents: https://op.europa.eu/o/opportal-service/download-handler?identifier=9d3355cf-591f-11ef-acbc-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=
- How much cost a Notified Body? – Links available: https://health.ec.europa.eu/document/download/ff5716d5-fe77-4f45-b883-fcf3da4acd15_en?filename=md_nbs_fees_en.pdf
Switzerland
- Swiss Combined Studies – Information Sheet to read: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw600_00_017e_mb_combined_studies.pdf.download.pdf/BW600_00_017e_MB_Information_combined_studies_KlinV_KlinVMEP.pdf
- 3D Printing for Medical Devices – Reminder from Swissmedic: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_017d_mb_3d-drucker_mep.pdf.download.pdf/MU600_00_017e_MB_3D_printers_medical_devices.pdf
Training
- EU MDR training September 23rd – Register Now: https://school.easymedicaldevice.com/course/gb33/
Events:
- RAPS Convergence – September 17th to 19th California: https://medtechconf.com/event/raps-convergence-2024/
- AI ACT SUMMIT – October 1st :Online : https://medtechconf.com/event/ai-act-summit/
- Team-PRRC – October 17th – Malaga: https://medtechconf.com/event/team-prrc-third-annual-summit/
- Afrisummit – November 3-6 – Egypt: https://www.pharmaregafrisummit.com/
- Meds’d – November 7th – Berlin: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
ROW
- Australia:
- Webinar: Software transition deadline on 1 November 2024 Reclassification needed: https://www.tga.gov.au/resources/event/webinars/software-reclassification-reforms-webinar-q-and-software-transition-deadline-1-november-2024
- USA
- Voluntary malfunction Summary Reporting (VSMR) – Support the system: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-malfunction-summary-reporting-vmsr-program-manufacturers
- FDA Webinar: Remanufacturing of Devices – Distinction between servicing and remanufacturing: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/webinar-final-guidance-remanufacturing-medical-devices-09102024?utm_source=FDALinkedin
- FDA DeNovo – Electronic Submission template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests
- PCCP Draft Guidance – Plan your changes so they don’t need a review again: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices
- Brazil:
- Brazil UDI project – The world will be UDI soon: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/saiba-mais-sobre-o-projeto-de-identificacao-unica-de-dispositivos-medicos
- Brazil Vigilance Reporting – e-Notivisa Launch: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/cidadaos-poderao-notificar-eventos-adversos-de-dispositivos-medicos-pelo-e-notivisa
- Singapore
- Singapore Change Management Program – Consultation on SaMD Guidance: https://www.hsa.gov.sg/announcements/regulatory-updates/consultation-on-guidance-on-change-management-program-(cmp)-for-samd
- Bahrain
- Guidance for registration of Medical Devices – Screenshot included: https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Device%20Importation%20Guideline-%20Ver%2011.1.pdf
Medical Device Live Expert:
- Medical Device Live Expert – July August:
- MDLE #2 – US EXPERT: Medical Device Live Expert #2 – US is in the place
- MDLE #3 – EU MDR and IVDR Future: MDLE #3 – The Future of the MDR in EU, What Is?
Podcast
- Podcast Nostalgia – July and August
- AI ACT – What are the challenges for Medical Devices? Fabien Roy https://podcast.easymedicaldevice.com/292-2/
- EU Battery Regulation – How to be ready? Erik Vollebregt: https://podcast.easymedicaldevice.com/293-2/
- How to register your Medical Device in the UAE? Ahmed Hendawy: https://podcast.easymedicaldevice.com/294-2/
- EU MDR majow update: Interruption or Discontinuation of Supply! Erik Vollebregt: https://podcast.easymedicaldevice.com/295-2/
- IVDR Class D – Lesson learned from Notified Bodies. Andreas Stange: https://podcast.easymedicaldevice.com/296-2/
- How to use Harmonised Standards for Devices? Beat Keller: https://podcast.easymedicaldevice.com/297-2/
- Manage the Transfer/Renewal/ Surveillance/Change of your CE Certificate. Ralf Gansel: https://podcast.easymedicaldevice.com/298-2/
- How to grow from Zero to Hero in Medical Device? Stephan O’Rourke: https://podcast.easymedicaldevice.com/299-2/
- Episode 300: How to use AI GPT for your QA RA work? Martin King: https://podcast.easymedicaldevice.com/300-2/
The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
10 September 2024, 12:58 am - How to use AI GPT for your Quality and Regulatory work?
In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.
Who is Martin King?
Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceuticals since 1979. Martin is a leading expert in quality assurance, regulatory compliance, and product development, developing active wearable devices since the 1980s.
Known for his hands-on approach and deep understanding of complex regulatory environments, Martin has guided companies around the globe through successful regulatory submissions. His expertise spans across six continents, making him a sought-after advisor in his field.
Martin holds advanced degrees in Micro-electronics and Materials Science, and Electronic Engineering. He is a trained Lead Auditor for ISO 13485:2016 and is well-versed in international standards such as 21 CFR 820 and MDR 745/2017. Recognized as one of the top 25 MedTech Leading Voices on LinkedIn, Martin also shares valuable insights through his popular weekly regulatory roundup.
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
- Martin Kings LinkedIn: https://www.linkedin.com/in/martink2/
- QARA Whatsapp group: https://chat.whatsapp.com/Dkl3XrjiXzW51Fgipf96k2
- QARA Whatsapp channel: https://whatsapp.com/channel/0029VaaBTj9CxoAwG0CUBn1x
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 use AI GPT for your Quality and Regulatory work? appeared first on Medical Device made Easy Podcast. hamza benafqir
5 September 2024, 10:09 am - More Episodes? Get the App
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