Easy Medical Device Podcast

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Medboard

https://www.medboard.com/

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

Blog post article: https://easymedicaldevice.com/legacy-devices-clarification-with-mdcg-2021-25/

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:

MDR: https://ec.europa.eu/docsroom/documents/62156/attachments/1/translations/en/renditions/native

IVDR: https://ec.europa.eu/docsroom/documents/62158/attachments/1/translations/en/renditions/native

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

Blog post: https://easymedicaldevice.com/how-can-i-do-my-post-market-surveillance/

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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:  https://www.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 

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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 Action

To 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 CAPAs

My 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 effectively

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

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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

Title: 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 - Subtitle: October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/

 Afrisummit - Subtitle: November 3-6, 2024: https://medtechconf.com/event/afrisummit/

 MEDICA - Subtitle: 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

Title: 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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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? 

Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She 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 became Head of UK Approved Body for DEKRA in 2022. She recently resigned and is spending some time creating accessible content to support manufacturers with the regulatory transitions being implemented across Europe. Claire has set up her own company, CAPD Consultancy Ltd, whilst building up a network to help identify the needs across the industry and provide the right type of help that manufacturers need.

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/fr-ma/

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/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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/

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