The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do.  Who is Beat Keller?  Beat is...

We have a lot of sort of Software as Medical Devices. Today I wanted to ask to Cesare Magri some questions about APIs. First what they are, and can they be a Medical Device. He will also give us some advice on what to do if your API is really a medical device. So stay tuned. 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...

EU: UDI for contact lenses  Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197 EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf MDCG 2023-4 guidance - Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf Fees and charges payable to EMA: Expert Panel will cost you money :...

This MDCG came like evidence but comments on it where more confusion. What exactly was the objective of the MDCG 2023-4. We will try to explain to you on this podcast with Erik Vollebregt from Axon Lawyers. 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...

The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. This is the part 2 where we will focus on the Egypt situation.   Check Part 1 for the first interviews with (https://podcast.easymedicaldevice.com/254-2/):  - Morad Ajan - Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco  - Rana Chalhoub - Regulatory Affairs Director at Mecomed.   - Dr. Mona Al Moussali - Co-founder PRA Consultancy and...

The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders.  First, I have the interview with Morad Ajan - Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) - Morocco. We reviewed the Quality and Regulatory situation of Morocco and learned a lot of good information about progress that the authorities are ongoing to be modernized.  Second, we have the interview with Rana Chalhoub - Regulatory Affairs Director at...

More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to talk to us about some pitfalls that you need to avoid.  Weronika will talk about:  - Risk Management  - Usability  - Documentation  - Expertise  - Interoperability and scalability  - Cybersecurity.  So don’t miss that and don’t hesitate to contact Easy Medical Device if you have some questions.  Who is Weronika...

EU Manual on Borderline and classification for Medical Devices Update - New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf Q&A on Annex XVI Products - Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf Italy: Custom-made medical device registration - Specific website available:...

EUDAMED is the European Database for Medical Devices. In this episode Richard Houlihan will be my guest and will explain to us the situation regarding EUDAMED. For the moment this database is not finished, so should you use it? We will also review the timeline and help you understand what you should do now. Don’t miss that episode as EU MDR 2017/745 and IVDR 2017/746 asks you to register your company, your products in this database. Who is Richard Houlihan? Richard Houlihan is an...

In this second part of this podcast serie on Team-Prrc interviews. we have 3 additional guests. Don't miss the first one where we also got great interviews. In this episode, we will interview - Bassil Akra about the Team-PRRC event and why you should come. This will happen again November 16th and 17th. - Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company - Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company -...

Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different economic operators The second one with Erik Vollebregt where we will review the role of a PRRC and liability The third one with Ronald Boumans where we will explain how to behave to be a PRRC And the last one with Christopher Kipp from BVMed on the PRRC role in Germany with the already existing safety officer. Don’t miss the next Team-PRRC...

EU o MDR and IVDR communication Survey • EU MDR transition • Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf • Flowchart to decision on the extended MDR transitional period: https://health.ec.europa.eu/document/download/2d29bd99-8523-4c13-bbf5-cc36fcecea93_en?filename=md_devices-art120_flowchart.pdf o Team-NB: New MDR Transition Timeline and Notified Body Capacity:...

Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how to clean it. In this episode of the podcast we will explain to you what is cleaning validation and also talk about microbiology, electrical device cleaning, Notified Body issues… So let’s listen to Enrico Allegra from TestLabs who will share with us his experience. Who is Enrico Allegra? Enrico has over 10 years of experience in...

We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is creating a more restrictive environment for accepting what was acceptable before. So let’s review in this episode the acceptance criteria for your Clinical Evaluation and what kind of surprises you would maybe discover all along the way. For that I have invited Cesare Magri from 4BetterDevices to help us understand this pathway and take the right road at the...

Software validation is key. This is mentioned on different standards, and this is required by the auditors to prove that your software is safe. This is valid for Software as a Medical Device SaMD but also to software used as a quality tool. ISO 13485 is asking you to validate software’s that are used to track quality data.  In this episode, Christophe Girardey and Viriginie Rochat from Wega will explain to us the next level of the software validation which is the automation. Imagine that...

Hiring a new candidate for your team is always a challenge. But how to do that when there is no Budget allocated to it. This is what we will show you in the podcast episode.   Mitch Robbins is a professional recruiter that has its own agency “The Anthony Michael Group”. He is able to help you on your research as he is specialised in QA RA recruitment. But he also knows your pain when your company cannot hire a recruiter for this mission. So, we will review what he proposes to you to be...

When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let’s listen to...

Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation.  For that I have invited Christophe Girardey from Wega to answer my questions...

Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software. The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor to say “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate you Quality tools and why this seem so important. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies...

I am sure that at a certain point, your company will try to market your medical devices in Saudi Arabia. And now you are looking for the information that will help you to accelerate the registration of the products. In this episode, Ahmed Hendawy from Registitute will help us understand the best strategy to do that. He will explain to us also the similarities between SFDA and EU MDR. So if you are really motivated to register your product within SFDA then this is the right podcast episode for...

Sponsor Medboard https://www.medboard.com/ EU Annex XVI transition EU MDR Domino is making more falls. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194New Timeline Until 31 December 2029 Cybersecurity and privacy in AI Medical imaging diagnosis https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosisANSM wants barcode on Field Safety Notice Why not all the other...

Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonise UK law with the MDR and IVDR) and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain a UKCA marks.   But what all this means for medical devices manufacturers that are already selling in the...

Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between the Software Development team and the Quality and Regulatory Affairs team. Dev team think that they have too much documents to create and quality thinks that the document that the dev team is creating is not really answering the requirements. So how to solve that.  Christophe Girardey from Wega who is dealing with that will tell us why we have...

Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer some frequently asked questions from people. As you may see on the title there are some great misunderstandings, and the objective of today is to clear that out.   For that I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on EU MDR extension.  Who is Florian Tolkmitt?  Florian Tolkmitt is...

Sponsor MedBoard: www.medboard.com  EUROPE  Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf  EU MDR and IVDR consolidated versions  EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320  EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320  Confirmation letter:  EU Commission:...