Easy Medical Device Podcast

Here are the links to the Regulatory Updates

HOT TOPIC

• EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf
• EU Call for application submission of EU Reference laboratories. https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en
• HPRA & Spain – EU Commission call for Member states application of EU Reference labs for IVDs (EURLs) –  http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/european-commission-publishes-call-for-european-union-reference-laboratories-for-ivds-designation&id=619f1226-9782-6eee-9b55-ff00008c97d0
• https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/instrucciones-para-la-presentacion-de-solicitudes-de-designacion-de-laboratorios-de-referencia-de-la-ue-para-productos-sanitarios-de-diagnostico-in-vitro/  
• Belgium FAMHP: https://www.famhp.be/en/news/call_for_belgian_laboratories_to_apply_to_become_the_european_union_reference_laboratory_for –
• Clinical Evaluation Consultation Procedure
  • CECP Class III implantable tricuspide valve procedure https://health.ec.europa.eu/latest-updates/expert-decision-and-opinion-context-clinical-evaluation-consultation-procedure-cecp-2022-08-24_en
  • CECP 2022-000213 Transcatheter heath valve   https://health.ec.europa.eu/document/download/3ed8dacb-2b9d-4096-bc84-0b408f8492c4_en?filename=cecp-2022-000213_opinion_en.pdf
• Draft Reclassification of Annex XVI products https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en

ROW

• SFDA introduction to regulation Workshop – REMOTELY: https://www.sfda.gov.sa/en/workshop/87146
• SAHPRA Guidances on clinical trial
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-07_v4-Guideline-for-Post-Clinical-Trial-Access.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-06_v2-Guideline-for-The-Procedure-of-Consultation-Meetings-with-Clinical-Trial-Applicants.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-04-Oversight-and-Monitoring-in-Clinical-Trials_August-2022_V4.pdf
  • https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-03-Emergency_Procedures_Clinical_Trial_Sites_August-2022_v3.pdf
• China – Guidance for registration of percutaneous Enteral Nutrition Catheter and Disposable Human Arterial Blood Samplers https://www.cmde.org.cn/flfg/zdyz/zqyjg/zqyjgwy/20220826111515137.html
• India: List of certified Medical Device Testing Laboratories under MDR 2017  https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg==
• Australia TGA – Regulatory Guidelines for Medical Devices https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

TRAINING

• Green Belt Session 20: https://school.easymedicaldevice.com/product/gb/
• Scube Technologies: https://scube-technologies.com/

NOTIFIED BODIES

• 32nd NB MDR – Bureau Veritas Italia https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15

GUIDANCES

• MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
• MDCG 2022-14 Transition to the MDR and IVDR: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf

EASY MEDICAL DEVICE PODCAST

• Medtech Europe Forum Interview https://podcast.easymedicaldevice.com/188/
• AI Act Erik Vollebregt https://podcast.easymedicaldevice.com/189/
• Cleanroom Philippe Bourbon Icare https://podcast.easymedicaldevice.com/190/
• How to create a Technical File https://podcast.easymedicaldevice.com/191/
• When you think 510k but FDA says DeNovo with Spencer Jones Lineus Medical https://podcast.easymedicaldevice.com/192/
• Discontinuation process with Alexandros Savvidis https://podcast.easymedicaldevice.com/193/
• New Blue Guide Erik Vollebregt https://podcast.easymedicaldevice.com/194/
• SaMD and SiMD Design Dossier Anindya Mookerjea https://podcast.easymedicaldevice.com/195/

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If you have developed a Software and you discover that it is considered a Medical Device, then what to do? Or your Software is inside a Medical Device so is this different than normal Medical Devices? In this episode with Anindya Mookerjea from Scube-technologies, we will explain to you the step that you need to follow to create a Design Dossier for your product. This is an important step as this is required for certification by the authorities. So let’s dig into it.

Who is Anindya Mookerjea?

Anindya is the founder and CEO of S-Cube Technologies. He has over 20 years of experience in the medical device & Software industry. Experienced in taking medical device concepts through design & development, regulatory submission, and to market. Expert in the design, development, and implementation of FDA/ISO compliant quality management systems for Medical devices & Software medical devices. Industry expert in Agile methodology implementation for Software medical devices. Strong background in testing Software medical devices. The brainchild of SmartEye product.

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 and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. 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 is also acting 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

• Anindya Mookerjea Linkedin Profile: https://www.linkedin.com/in/anindya-mookerjea-6b5367209/
• SCube Technologies website: https://scube-technologies.com/
• SCube Technologies Linkedin Page: https://www.linkedin.com/company/scube-technologies/
• Twitter account: https://twitter.com/scubetechno
• Facebook account: https://www.facebook.com/i.scubetechnologies
• Article Medical Device development: https://easymedicaldevice.com/medical-device-development/

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

The new Blue Guide is out. So what are the changes for Medical Device Manufacturers? Erik Vollebregt will give us his analysis and also some revelation on the Swiss MRA process if you are still in need of the situation in Switzerland.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and personal data protection. 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 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 a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company is also acting as Authorized Representative for the EU, UK, and Switzerland? Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt
• Axon Lawyers: https://www.axonlawyers.com/
• Blue Guide link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC
• Blog Blue Guide: 2022 Update: https://medicaldeviceslegal.com/2022/08/07/the-blue-guide-2022-update-new-elements-regarding-applicability-of-eu-law-on-products/

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

This is really a good question. Sometimes, we are looking at the portfolio of some companies and ask "How many products on this portfolio are sold in less than 5 units per year" One company with 1200 references showed me an excel sheet with 500 references that are available but with really low volume of sales. This cost stock, regulatory update work, continuous improvement... So let's talk with Alexandros Saavidis about Discontinuation and I hope this will convince you to embrace this practice.

Who is Alexandros Savvidis?

Alexandros Savvidis is a Senior Medical Device Specialist active for more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis. After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes. Alexandros has gained one overall experience and deep understanding through his various roles in the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations. He has worked on small, middle-size companies alone or as a team member, or even on cross-functional teams of Life Science Giants. In the last years, his main focus is the implementation of MDR requirements and updates

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 and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses...

Links

• ■ Discontinuation process Download: https://mailchi.mp/easymedicaldevice/discontinuation
• ■ Alexandros Linkedin Profile: https://www.linkedin.com/in/alexandrossavvidis/

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.

This episode will explain to you the journey of the company Lineus Medical when they tried to register their products in the USA. Initially, they prepared the product to be registered with the 510k Regulatory Pathway but the FDA did not agree and said that they should go through DeNovo. So Spencer Jones who founded the company will tell us how they have done that and he will also give some tips on how he would have done it today if he had to restart again. So benefit from his journey to learn how you should do it.

Who is Spencer Jones?

Spencer worked for three years in direct patient care as a Certified Nursing Assistant, Licensed Practical Nurse, and as a Registered Nurse. Frustrated with the inefficiencies plaguing the healthcare system, he was determined to improve the delivery of healthcare. While still working as a nurse in the clinical setting, Spencer identified opportunities where improvement was needed around IV complication prevention. This led to the creation of SafeBreak® Vascular and the founding of Lineus Medical in 2015. Spencer graduated from the University of Arkansas with a Bachelor in the Science of Nursing. Spencer is on the Fayetteville Innovation Council and was the Entrepreneur in Residence for the Hub X Life Sciences Accelerator for 2016. He has three issued U.S. patents and several others pending.

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 and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links

• Spencer Jones LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/
• Lineus Website: https://www.lineusmed.com
• FDA DeNovo guidance: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

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 creation of a Technical File or Technical Documentation for CE marking is really a challenge sometimes. After successfully passing audits with my customers, I want to share with you some best practices to create your Technical Documentation. I will even explain to you how to reference your annexes or what to do with the GSPR. So don’t miss it.

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 and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links

• EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424
• EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128#tocId129
• How to comply with GSPR: https://easymedicaldevice.com/gspr/
• Technical Documentation blog post: https://easymedicaldevice.com/technical-documentation/
• How to write your declaration of conformity: https://easymedicaldevice.com/declaration-of-conformity/
• eQMS Scube SmartEye: https://scube-technologies.com/
• Easy Medical Device Shop: https://school.easymedicaldevice.com/shop/

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.

Cleanroom is an equipement that a lot of Medical Device manufacturer need to have. But do you really need it? How much does it cost? How to qualify it? How to maintain it? Philippe Bourbon from Groupe Icare Laboratory will help us understand all that. Check also the summary provided as a download.

Who is Philippe Bourbon?

Physician, passionate about topics related to particulate, microbiological and chemical contamination on industrial sites and health sectors. 30 years of experience, knowledge in a Cofrac and cGMP / BPF environment, Consulting / Training, Expert in contamination control, and sterilization processes, Sales, Technical Developments, Management of technicians, managers and salespeople , Activity Manager. Expertises: Sterilization by heat, S.I.P., Ethylene oxide, depyrogenation, cleanrooms and controlled environment, microbiological and chemical confinement, climatic and thermostatic chambers, compressed gas Pharmaceutical Regulation (GMP / cGMP), Medical Devices, Standards (ISO14644, ISO17665, FDX15-140, …) Diagnosis / Consulting / Validation strategy / Qualifications / Audits / Trouble shooting

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 and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now made the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

Links

• Philippe Bourbon Linkedin: https://www.linkedin.com/in/philippe-bourbon-a3227818/
• Groupe Icare website: https://www.groupeicare.com/en/home/
• Download cheat sheet: https://mailchi.mp/easymedicaldevice/190
• eQMS Scube SmartEye: https://scube-technologies.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 you are working in the development of Software, then this is maybe something that will be interesting for you. The EU is preparing legislation for Artificial Intelligence and we will talk with Erik Vollebregt about the potential compatibility with the EU MDR 2017/745 This new legislation is not focused on Medical Devices but on all software that may contain AI. So if you are impacted, learn what will maybe come within your scope soon.

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 a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Recently, Monir is becoming a partner of Scube Technologies for the creation of the eQMS Scube SmartEye specialized for Medical Device companies. Check the link below.

Links

• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt?miniProfileUrn=urn%3Ali%3Afs_miniProfile%3AACoAAACQIeoBwNcVRqemNbX4xB92OSXiqh6ax58&lipi=urn%3Ali%3Apage%3Ad_flagship3_search_srp_all%3BIfAX1Az4TkG6EaE1%2Bb%2BZ1g%3D%3D
• Axon Lawyers: https://www.axonlawyers.com/
• AI Act report: https://www.government.nl/documents/publications/2022/05/25/legal-analysis-european-legislative-proposal-draft-ai-act-and-mdr-ivdr
• AI Act original proposal: https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2021/0206/COM_COM(2021)0206_EN.pdf
• Track progress AI Act: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2021/0106(COD)&l=en
• Axon Lawyers powerpoint presentation: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/07/AI-and-devices-puzzel-MedTech-Summit.pptx
• AI Act amendment: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/07/AI_Act_Ammendments_Drago_Tudorache_1655544378.pdf
• Compromise text AI Regulation: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/07/Compromise-text-AI-Regulation-ST_14278_2021_INIT_en.pdf
• eQMS Scube SmartEye: https://scube-technologies.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.

During my visit to the Medtech Europe Forum in Barcelona in May 2022, I had the chance to interview key people in the industry. I am sharing these interviews:

• Fabien Roy is sharing with us his experience as a lawyer with Notified Bodies.
• Peter O’Blenis has introduced me to his software Distiller SR and I had the chance to get a DEMO which was really great
• Ronald Boumans explained to me the possible opportunity that can carry EUDAMED for industries
• Inna and Rana from Mecomed were also at the conference which was the occasion to get introduced to this organization equivalent to Medtech Europe but in the Middle East.

All the LinkedIn links are below.

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 the Medical Device Regulations worldwide. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Monir is also a partner with the project Scube Smarteye which developed an eQMS specific for the Medical Device industry. Check the link below.

Links

• Medtech Europe: https://www.medtecheurope.org/
• Fabien Roy: https://www.linkedin.com/in/fabien-roy-83b55021/
• Peter O’Blenis: https://www.linkedin.com/in/peteroblenis/
• Ronald Boumans: https://www.linkedin.com/in/ronald-boumans-34790055/
• Rana Chalhoub: https://www.linkedin.com/in/rana-chalhoub-8a391214/
• Inna Nadelwais: https://www.linkedin.com/in/inna-nadelwais/
• Scube Smarteye: https://scube-technologies.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.

This month the Regulatory update will contain a lot regarding Artificial intelligence for medical devices. All the links that are mentioned can be downloaded from the link below. Don’t hesitate to contact Easy Medical Device if you have a question on Quality and Regulatory Affairs for medical devices.

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 and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

Links from the Video

Download the July 2022 Regulatory Update document: https://mailchi.mp/easymedicaldevice/july2022

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.