In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA. Who is Cyrille Michaud ? Co-founder and managing partner of MD101 Consulting. Consultant in Quality Assurance and Regulatory Affairs for software in medical de...
Apr 10, 2025
Sponsor: Medboard Europe Certificates under Condition – Team NB press release: https://www.team-nb.org/wp-content/uploads/2025/03/PressRelease-WP3-Task3.3-Certificates-with-Conditions-20250312.pdf European Artificial Intelligence Office -A new expert panel for AI Medical Devices: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500454 UK invented the AIaMD – Fewer law but more guidance: https://www.gov.uk/government/publications/the-regulation-of-artificial-intelligence-as-a-medic...
Apr 04, 2025
In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned. Who is Darrin Carlson ? Darrin Carlson has over ten years of experience in Quality and Regulatory in the medical device, pharmaceutical, and combination product fields. In addition to his current role as a Regulatory Affairs Specialist, he also helps sm...
Mar 20, 2025
Sponsor Medboard: https://www.medboard.com/ Europe Health Data Legislation – Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500327&qid=1741166600030 FAQ: https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf eIFU proposal until March 21st- eIFU for professional user: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14470-Medical-devices-electronic-instruction...
Mar 13, 2025
In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let’s clarify all this and give you the right strategies for your Medical Devices. So stay tuned. Who is Hatem Rabeh ? Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices. With over 8 years of experi...
Mar 06, 2025
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? Michelle will explain if you can be part of this and how to do it also. So stay tuned. Who is Michelle Lott ? Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grie...
Feb 27, 2025
In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project. On some of my consulting projects, I ask people if they can send me their Risk Management File, which usually follows by “I don’t have one” and then by “How can we create one?”. So Today Bijan Elahi who is an expert on risk management will explain the best way to start such project. Who is Bijan Elahi ? Bijan Elahi has worked in risk management for medical devices for over 30 ...
Feb 20, 2025
In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you’ll see that this is not all good. Who is Mark Rogovoi ? Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhsta...
Feb 13, 2025
Medboard EU EU MDR and IVDR article 10a – Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods – Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdf EUDAMED EMDN: UPDATE or not to UPDATE – MDCG 2024-2 Rev 1 and 2021-12 Rev 1 : https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pd...
Feb 06, 2025
In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic. 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 Syste...
Jan 30, 2025
In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you. 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...
Jan 23, 2025
In this episode, Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a Drug-Device Combination or DDC and then identify some case studies. She will also provide us with the guidances that we should follow. Who is Joan D’Souza ? I have experience in pharmacovigilance, regulatory affairs, medical writing, and law (JD, licensed to practice law in the state of Minnesota, US). I offer future employers dedication, a passion ...
Jan 16, 2025
In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa. Who is Khanyisile Nkuku? Ms Khanyisile Nkuku In her current role as a Medical device &a...
Jan 09, 2025
Stefan bolleininger will share with us information regarding Artificial intelligence and MDR. This presentation happened during Medica 2024. So if you have any questions you can ask ok the comments. 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 ...
Jan 02, 2025
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 worl...
Dec 26, 2024
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...
Dec 19, 2024
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/e...
Dec 12, 2024
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...
Dec 05, 2024
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 o...
Nov 28, 2024
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 Documen...
Nov 21, 2024
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...
Nov 14, 2024
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 regula...
Nov 07, 2024
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-...
Oct 31, 2024
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 Si...
Oct 24, 2024
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 Corr...
Oct 17, 2024
Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en...
Oct 10, 2024
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 towar...
Oct 03, 2024
In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US. Who is Claire Dyson? Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body ...
Sep 24, 2024
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 clinic...
Sep 17, 2024
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-speci...
Sep 10, 2024
