MDRChats-by ChatMDR
ChatMDRMDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (chatmdr.eu/). Information on the latest updates, insights, and guidance documents; all designed to keep you informed and ahead in your field. Whether you're on your commute, taking a break, or just prefer listening over reading, MDRChats is designed to f... more
| Publishes | Daily | Episodes | 20 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Categories | CareersBusiness | ||||
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Latest Episodes
This episode breaks down how the AI Act works alongside MDR and IVDR, how to avoid unnecessary duplication, and what’s required for quality management, technical documentation, and post-market monitoring.
The podcast includes MDCG 2025-4 guidance on making medical device software (MDSW) apps available via online platforms — including key definitions, roles under the MDR/IVDR and DSA, and what this means for manufacturers and app stores.
It also Inclu... more
A concise guide to the MDR Certification Process, based on the Team-NB Consensus Document, covering pre-application, application, and post-certification phases.
In this episode of MDR Chats, we explore the key update in MDCG 2019-13 Rev. 1: the temporary reduction of sampling requirements from 15% to 5% for MDR Class IIa/IIb and IVDR Class B/C devices. Learn what this means for manufacturers and notified bod... more
In this episode of MDR Chats, we dive into the Master UDI-DI solution for contact lenses, guided by the MDCG 2024-14 document. Hosts Oliver Harris and Dr. Sarah Bennett explore UDI basics, labelling requirements, Eudamed registration, and the complia... more
Dive into the latest regulatory updates with host Oliver Harris as he explores MDCG 2024-15, the guidance on publishing clinical investigation reports and summaries in the absence of EUDAMED. Joined by Dr. Eleanor Bennett, a clinical investigations s... more
In this episode of MDR Chats, Dr. Emily Clarke discusses the regulatory challenges and considerations for AI in medical devices. Topics include the roles involved in AI, ensuring device safety for lay users, assessing risks from imbalanced datasets a... more
Join us for an in-depth discussion on the European Commission's latest Q&A document (November 2024) addressing the gradual roll-out of EUDAMED. We explore key deadlines, practical implications for manufacturers, notified bodies, and other stakeholder... more
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MDRChats-by ChatMDR launched 2 years ago and published 20 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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