🚀 From Google Podcasts to Moon FM in No Time: Your Hassle-Free Migration Guide
👉
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.
- Easy Medical Device Great Summary 2024
In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. He will explain the situation in Consulting, Representation, eQMS , eIFU project, Medtech Conferences, Podcasts Episodes, Topra Awards and all the future projects in 2025.
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.
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 Easy Medical Device Great Summary 2024 appeared first on Medical Device made Easy Podcast. hamza benafqir
26 December 2024, 12:00 am - What are the major pitfalls of Startups in Medical Devices?
In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. He will provide his advice so you can be successful and already know some issues that you may encounter as a Startup
Who is Adnan Asfaq?
Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.
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:
- Adnan Ashfaq LinkedIn: https://www.linkedin.com/in/adnan-ashfaq-44478121/
- Simplimedica website: https://simplimedica.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 are the major pitfalls of Startups in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
19 December 2024, 12:00 am - Medical Device News December 2024 Regulatory Update
MEDBOARD: https://www.medboard.com/
EUROPE
- TEAM-NB high level position – Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf
- MDCG 2024-15 – Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf
- EMA activities on Combination products – Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf
- MDCG 2024-16 Interruption or Discontinuation – For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf
- Joint Paper from 9 Member states – Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf
- Reduction of Administrative Burdens
- Centralization of System Management to the EMA
- Predictable Certification Procedures
- Enhanced Coordination and Support
- Impact Assessment and Resource Allocation
- MDCG 2024-14 Master UDI-DI – Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf
- Master UDI-DI Assignment
- Labelling Requirements
- Vigilance Reporting
- EUDAMED Registration
- Implementation Timeline
- Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf
- Gradual Roll-out of EUDAMED – Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
- Spain application for in-house devices – For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/
SMARTEYE
- Eqms Smarteye: https://eqms-smarteye.com/
EVENTS
- Arab Health – January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/
TRAINING
- Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/
ROW
- US – Some healthcare software are not devices – WARNING: https://www.fda.gov/media/184083/download?attachment
- Administrative support in healthcare settings.
- Promoting healthy lifestyles without direct links to disease management.
- Serving as electronic patient records without interpreting or analyzing data.
- Transferring, storing, converting, or displaying medical data without interpretation.
- Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.
- US – PCCP Final guidance – Submit a PCCP with your submission: https://www.fda.gov/media/166704/download
• Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin
- South Korea Guidance – Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564
- Australia – Guidelines for Medical Devices – Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd
- Australia – Submit Custom-made device – Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification
- Malaysia – Advertisement application – Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement
PODCAST
- How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/
- Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/
- How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/
- IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/
- PCCP – The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/
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 December 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
12 December 2024, 12:00 am - PCCP – The Magic tool for SaMD in the US?
In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regarding changes to SaMD.
Who is Maria Diez?
María Diez is a seasoned expert in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices and in vitro diagnostic devices (IVDs), with over a decade of professional experience in the field. Holding a Ph.D. in Biochemistry and Molecular Biology, María has specialized in developing and maintaining Quality Management Systems (QMS) in compliance with standards such as ISO 13485, ISO 14971, and IEC 62304. She also brings extensive expertise in ensuring compliance with international medical device regulations, including those of the FDA, MDR, and IVDR. Additionally, María has significant experience in integrating advanced technologies, such as Artificial Intelligence (AI) and cybersecurity, into medical device software (MDSW) and Software as a Medical Device (SaMD).
Currently, María serves as a QA/RA Consultant at CMG MedDev, where she assists medical device manufacturers in bringing safe and effective products to market. Her expertise includes preparing technical documentation for CE marking, managing regulatory submissions for non-European markets, and helping companies navigate evolving global regulatory landscapes. María’s passion for education and innovation drives her active participation in industry conferences, where she shares her knowledge on AI-based MDSW/SaMD development and her experiences as a PRRC during the certification process.
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
- Maria Diez LinkedIn: www.linkedin.com/in/maría-diez-zaera-46460323
- CMGMedDev website: https://www.linkedin.com/company/cmgmeddev/posts/
- PCCP guidance US:
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices
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 PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast. hamza benafqir
5 December 2024, 12:00 am - IEC 60601-1-8 How to test your Medical Device alarms?
In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so obvious.
Who is Beat Keller?
Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC.
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
- Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/
- SMDC website: https://www.smdc.ch
- IEC 60601-1-8 Alarm System: https://webstore.iec.ch/en/publication/59648
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 IEC 60601-1-8 How to test your Medical Device alarms? appeared first on Medical Device made Easy Podcast. hamza benafqir
28 November 2024, 12:00 am - How to build the perfect Quality Management System?
In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do.
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
- Blog: Does your Quality Manual look like that? https://easymedicaldevice.com/quality-manual/
- Video: How to get ISO 13485 certified? https://www.youtube.com/watch?v=paT2oR0uwjg
- ISO 13485 standard: https://knowledge.bsigroup.com/products/medical-devices-quality-management-systems-requirements-for-regulatory-purposes?version=tracked
- Blog: ISO 13485 Mandatory procedures: https://easymedicaldevice.com/iso-13485-procedure/
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 build the perfect Quality Management System? appeared first on Medical Device made Easy Podcast. hamza benafqir
21 November 2024, 12:00 am - 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 - More Episodes? Get the App
About Medical Device made Easy Podcast
Global Medical Device Podcast powered by Greenlight Guru
Medical Device Talent Podcast
Medsider: Learn from MedTech and HealthTech Experts
Medtech Talk
Your feedback is valuable to us. Should you encounter any bugs, glitches, lack of functionality or other problems, please email us on [email protected] or join Moon.FM Telegram Group where you can talk directly to the dev team who are happy to answer any queries.
© MoonFM 2024. All rights reserved.