Easy Medical Device Podcast

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

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

Who is Erik Vollebregt? 

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

Who is Monir El Azzouzi? 

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

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

Link: 

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ 

Axon Lawyers Website: https://www.axonlawyers.com/ 

Erik Blog: https://medicaldeviceslegal.com/ 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

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

Who is Adam Isaacs Rae? 

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

Who is Monir El Azzouzi? 

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

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

Link: 

Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/ 

ISO 11137- Radiation standards : https://www.iso.org/standard/33952.html 

ISO 11607 – Packaging of terminally sterilised products: https://www.iso.org/standard/70799.html 

ISO 11737 – Bioburden: https://www.iso.org/standard/66451.html 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

Sponsor:

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

EU

MDR and IVDR national languages update - France accepts English

MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf

IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf

Which devices for Expert Panel - Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf

94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products

On Class III implantable - Top is with Active Implantable Devices

Exempt devices are mainly within 3 categories (Main reason: Modification of a device already marketed):

Vascular and cardiac prostheses

Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligaments synthesis

Implantable prosthetic and osteosynthesis devices

Annex XVI: Is Brain Stimulation device risk? -  SCHEER should evaluate by End 2025: https://health.ec.europa.eu/document/download/e6de1e88-2821-48f6-98f9-a56ea61cbfad_en?filename=scheer_q_031.pdf

SCHEER = Scientific Committee on Health, Environmental and Emerging Risks

SCHEER on Phtalate - Update of the guidelines: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-update-scheer-guidelines-benefit-risk-assessment-presence_en

Consultation until April 28th, 2024

MDCG subgroup Agenda - What is coming?: https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf

MDCG 2024-3 on CIP - Clinical Investigation: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en.pdf

New Notified Body RISE Sweden - Welcome to the team 3033: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=d37c034bc695d2e143b5145b4cb7cd73caf8983c&group=NOTIFICATION&download=true

44 MDR NB

12 IVDR NB

UK

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

Ireland

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

Turkey

Reminder on MDR transition period - May 26th, 2024: https://titck.gov.tr/storage/Archive/2024/announcement/duyurumetni_67231ed0-2553-4708-8231-7951c767e066.pdf

Turkey strongly inform the different parties regarding MDR transition

Events

RAPS Euro Convergence - May 6-8 in Berlin-Germany: https://www.raps.org/europe-2024/home

Medtech Conf Map: https://medtechconf.com/event/connect-with-european-andinternational-regulatoryaffairs-peers-in-berlin-2/

Services

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

ROW

USA

Ban devices - Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans

CNN article: https://edition.cnn.com/2024/03/25/health/fda-ban-electrical-stimulation-devices/index.html

Comments open until May 28, 2024: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-proposes-new-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior

Bans

Prosthetic Hair Fibers since 1983

Powdered Surgeon's Gloves since 2017

Electrical Stimulation Devices for Self-injurious or Aggressive Behavior since March 2024

Animal Studie for Dental Bone Grafting devices - Choose the right animal Model: https://www.fda.gov/media/177340/download

Minimum of 3 animals

Animal Model: Canine and Porcine model instead of rodents

FDA: Deviations on Neuralink lab - Animal Study good practices: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/

Calibration of equipment's are not done

Quality officials not signing documents

Australia

Vigilance Reporting in Australia - For Recall and non-Recall: https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf

Recall action Template: https://www.tga.gov.au/resources/resource/forms/recall-action-templates

Saudi Arabia

Guidance on Surgical Sutures - This contains some cheat code: https://www.sfda.gov.sa/sites/default/files/2024-03/%28MDS-G021%29En.pdf

Endpoints that should be addressed

Laboratories should be ISO/IEC 17025

Shelf life should follow ASTM F1980

Brazil

MOU between Brazil and Paraguay - Memorandum of Understanding: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-e-agencia-reguladora-do-paraguai-assinam-primeiro-memorando-de-entendimento

Bilateral cooperation on health surveillance

Strenghtening regulatory capacity

GMP validity from two to four years - If certified through MDSAP: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-amplia-para-quatro-anos-prazo-de-validade-do-certificado-de-boas-praticas-de-fabricacao

Prioritize registration of Dengue Diagnosis Devices - Submit Now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-prioriza-registro-de-dispositivos-para-diagnostico-da-dengue

Combat dengue epidemic as a matter of urgency

India

CDSCO: PSUR through online portal - From April 1st, 2024: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwMTI=

Online portal: https://www.cdscomdonline.gov.in/NewMedDev/Homepage

Malaysia

Malaysia Faster approval - Establishment license application: https://www.mda.gov.my/index.php/announcement/1377-faster-approval-for-establishment-license-application-complete-applications-processed-within-14-21-working-days

14 to 21 Working days from date of application

List of documents within the link

China

China Guidelines on registration - Specific products: https://www.cmde.org.cn/xwdt/zxyw/20240318133300123.html

Corneal Topograph

Laparoscopic surgery system

Optical Radiation Safety device

Monkeypox virus nucleid acid detections agent: https://www.cmde.org.cn/xwdt/zxyw/20240318111545184.html

Podcast

Podcast Nostalgia

Episode 275 - FDA aligns QMSR with ISO 13485 (Naveen Agarwal): https://podcast.easymedicaldevice.com/275-2/Episode 276 - How to do Postmarketing Surveillance to right way? (Steve Curran): https://podcast.easymedicaldevice.com/276-2/

Episode 277 - How to benefit from Survey to build Clinical Evidence? (Cesare Magri): https://podcast.easymedicaldevice.com/277-2/

Easy Medical Device

[email protected]

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

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

Who is Cesare Magri? 

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

Who is Monir El Azzouzi? 

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

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

Link: 

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

Linkedin Post User Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-survey-activity-7175785619837595648-aRxY 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

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

Who is Steve Curran? 

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

Who is Monir El Azzouzi? 

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

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

Link: 

Steve’s LinkedIn: https://www.linkedin.com/in/stephencurran/ 

Blog on PMS: https://www.trinzo.com/medical-device-pms 

PMS Training: https://www.meddevsolutions.co.uk/course/pms-training 

Trinzo Website: www.trinzo.com 

Trinzo LinkedIn: https://www.linkedin.com/company/trinzo  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

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

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

Who is Naveen Agarwal? 

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

Who is Monir El Azzouzi? 

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

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

Link: 

Naveen Agarwal Linkedin Profile: https://www.linkedin.com/in/naveenagarwal/ 

Learn more about Let's Talk Risk! here ans subscribe:

https://naveenagarwalphd.substack.com/about 

Webinar recording - Getting Ready for QMSR:

https://naveenagarwalphd.substack.com/p/webinar-5-getting-ready-for-qmsr  

Risk management training on ACHIEVE: 

https://www.achievexl.com/ 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

 Sponsor:

Medboard

EU

EU proposal to prevent shortage - And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/

Notified Body Survey - Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf

Spain: AEMPS consultation - Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/

EURL Second Call - More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en

TEAM-NB Position Paper - Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/02/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf

EMDN Proposal - Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/

MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf

Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf

Training

Training Green Belt EU MDR - Learn by practicing: https://school.easymedicaldevice.com/course/gb30

Open March 25th, 2024 until March 29th, 2024TEAM-NB Training - Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdfApril 29th, 2024

Services

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

ROW

USA

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

CANADA

Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html

Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html

Mexico

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

Saudi Arabia

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

Qatar

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

Australia

TGA SOPP requirements - System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf

TGA Essential Principles - Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf

Transition to EU MDR cases - Evidence of transition, DCR, Non-Compliance, Recalls:

https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf  

https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf

https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf

https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf

PODCAST

Episode 271 - How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/

Episode 272 - Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/

Episode 272 - New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/

EASY MEDICAL DEVICE Services:

Training: https://school.easymedicaldevice.com/emd-course/

Authorized Representative EU: https://easymedicaldevice.com/eu-rep/

Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/

Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/

Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/

Eqms SmartEye; https://smart-eye.io

Conferences: https://medtechconf.com/

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

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

Who is Erik Vollebregt? 

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

Who is Monir El Azzouzi? 

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

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

Link: 

Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ 

Axon Lawyers Website: https://www.axonlawyers.com/ 

Erik Blog: https://medicaldeviceslegal.com/ 

Linkedin post: https://www.linkedin.com/posts/erikvollebregt_medical-devices-council-endorses-new-measures-activity-7166021646573641730-abCh 

Medical Devices: Council endorses new measures to help prevent shortage: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/?utm_source=dsms-auto&utm_medium=email&utm_campaign=Medical+devices%3a+Council+endorses+new+measures+to+help+prevent+shortages 

Proposal text: https://data.consilium.europa.eu/doc/document/ST-6156-2024-INIT/en/pdf 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

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

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

Who is Christina Ziegenberg? 

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

Who is Monir El Azzouzi? 

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

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

Link

BVMed website: www.bvmed.de 

BVMed link: https://www.bvmed.de/de/english/bvmed-services?pk_campaign=tsr_CHK&pk_kwd=english_tsr-aktuelles-gT_mi_bvmed-services  

Current BVMed Position Paper in German: https://www.bvmed.de/download/positionspapier-ethylenoxid  

BVMed Position Paper with regards to the public consultation: https://www.bvmed.de/download/bvmed-positionspapier-ethylenoxid-einstufung-nach-biozidverordnung-bpr  

Information regarding EtO from ECHA: https://echa.europa.eu/de/information-on-chemicals/biocidal-active-substances/-/disas/factsheet/1304/PT02 

Assessment report: https://echa.europa.eu/documents/10162/3e7d946a-6939-2f2e-252e-dcd03d9ea36e  

BPC Opinion: https://echa.europa.eu/documents/10162/5a3831c0-e6d4-7140-1e1b-2c8e3369edd4 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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

You are maybe about to take a new job and you find out this episode of the podcast on how to prepare for an interview. I must say that we have invited the expert in recruitment for Medical Devices Elena Kyria from Elemed.  

She will give you all the hints, tips to make your interview a success. So don’t miss this episode and don’t forget to raise your comments on the show notes. 

Who is Elena Kyria? 

Elena Kyria is an award winning talent acquisition specialist, and CEO of Elemed. Elemed  helps companies hire exceptional talent, and helps top QA/RA talent reach brilliant companies. She also coaches and supports top talent on how to build a strong professional brand, to help maximise career possibilities, and leads an executive podcast “career diaries in medtech” designed to inspire the next generation of medtech professionals

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: 

Elena Kyria LinkedIn Page: https://www.linkedin.com/in/elenakyria/ 

Elemed Website: https://www.elemed.eu/ 

Linkedin Post: https://www.linkedin.com/posts/elenakyria_pushpull-factors-job-interviews-activity-7161295184008257536-w-ub 

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.