Hosted by ChatMDR · 🇺🇸 US · EN · 18 episodes
Established thought leaders with verified media credentials.
MDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (https://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 fit seamlessly into your day. Our episodes transform your available moments into productive insights on regulatory changes.
ChatMDR hosts MDRChats-by ChatMDR, a business show with 18 episodes published.
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
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
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
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 Bennet
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 ri
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
In the latest MDR Chats episode, we dive into the new guidance on Article 10a covering manufacturers' obligations for supply interruptions and discontinuations. Highlights: Essential timelines and reporting duties Risk f
In this episode, Oliver Harris delves into the specific requirements under the MDR as they apply to legacy devices, based on MDCG 2021-25 Rev. 1. He covers essential obligations for manufacturers, authorised representati
In this episode, Oliver Harris discusses the newly published guidance document MDCG 2024-13 with a regulatory expert. The document, titled 'Regulatory Status of Ethylene Oxide (EtO) Intended for the Sterilisation of Medi
In this episode of MDRChats, host Oliver Harris interviews medical device compliance expert Dr. Emma Lawson to clarify the differences between Annex 9, Annex 10, and Annex 11 under the Medical Device Regulation (MDR). Th
In this episode of MDR Chats, host Oliver Harris interviews an expert about the MDCG 2023-7 guidance document. They discuss the concept of ‘sufficient levels of access’ to data needed to justify claims of equivalence for
Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Thompson about the latest revisions in standardisation for medical devices. Stay updated with essential insights on the new MDCG document pu
Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Collins about the clinical evaluation of orphan medical devices. Discover the unique challenges and considerations in developing, testing, a
A risk-based statistical sampling plan for medical devices adjusts sample sizes and testing criteria according to the potential impact of failures, guided by historical data and risk assessments. This method efficiently
In this podcast, regulatory experts discuss the extended deadlines under the Medical Device Regulation (MDR), focusing on the transitional periods for various classes of medical devices.
In this episode of MDR Chats, we delve into the intersection of artificial intelligence and medical device regulation under the new EU Artificial Intelligence Act. This episode is created by chatMDR.eu . The voices in th
Better understanding of the PRRC's role, responsibilities, and operational considerations for manufacturers and other economic operators. The voices in this podcast are AI-generated.
MDRChats is your go-to podcast for the latest insights and updates on Medical Device Regulation, tailored for those with busy schedules. Our episodes are designed to enhance your understanding of MDR, keeping you informe
Sarah Bennett
Dr. · HPR
1 appearance on this show
Emily Clarke
Director of Development · Highgate School
1 appearance on this show
Emily Bennett
Account Manager · Shift•ology Communication
1 appearance on this show
Emma Lawson
medical device compliance expert · CrossFit Elmira
1 appearance on this show
expert
Canada Revenue Agency
1 appearance on this show
Emily Thompson
Director of Funfest and Special Events · Visit Kingsport
1 appearance on this show
Emily Collins
Environmental Services Manager · Ho-Chunk Nation Housing Department
1 appearance on this show
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MDRChats-by ChatMDR is hosted by ChatMDR. The show is categorised under business (careers) and has published 18 episodes.
MDRChats-by ChatMDR has published 18 episodes.
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