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MDRChats-by ChatMDR
ChatMDR
20 episodes
1 day ago
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.
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All content for MDRChats-by ChatMDR is the property of ChatMDR and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Show more...
Careers
Business
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MDR Requirements for Legacy Devices: Insights from the Latest MDCG Revision (MDCG 2021-25 Rev. 1)
MDRChats-by ChatMDR
17 minutes 7 seconds
1 year ago
MDR Requirements for Legacy Devices: Insights from the Latest MDCG Revision (MDCG 2021-25 Rev. 1)

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 representatives, importers, and distributors, including quality management systems, technical documentation, vigilance reporting, and post-market surveillance. Key exemptions for legacy devices are also highlighted, along with important transitional provisions. The discussion emphasizes the balance between regulatory compliance and patient safety during the MDR transition period.

MDRChats-by ChatMDR
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.