Qserve's Highlights of October

Qserve's Highlights

Hot topics from the month of October

Each day our Qserve experts share in-depth content on our website and LinkedIn page. These posts are most popular with our readers. If you want to receive this update in your mailbox, click here and stay up to date!

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Qserve's October Highlights:

October 22, 2021

New MDCG guidance on legacy devices – Initial thoughts

On October 20th the MDCG group published two new guidance documents, one related to article 16 (MDCG 2021-26) and one to legacy devices in the transitional period (MDCG 2021-25).
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October 21, 2021

On-Demand Webinar | MDSAP Mock Audits - Prepare yourself with practising for predictable compliance

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October 14, 2021

MDCG 2021-24 Guidance on classification of medical devices

We have been longing for it since the MDR was first published and now eventually some guidance on device classification is available. Was it worth the wait? Well, to some extent it was.
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October 14, 2021

IVDR Extended Transition Proposed – but don’t take your foot off the gas!!!

The Commission has issued a proposal for extending the transitional arrangements for the IVDR. This is not a simple unilateral extension so there are winners and losers.
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October 05, 2021

New guidelines on the use of the Nonconformity Grading System for MDSAP purposes (MDSAP AUP0037.001) have been published: An analysis of changes and their impact. 

A new MDSAP document (Guidelines on the use of Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange (GHTF/SG3/N19:2012) for MDSAP purposes) has recently been published. Read about all the changes. 
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