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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.

MDCG Medical Device Regulations

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.

In-Vitro Diagnostics

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October 22, 2021

New MDCG guidance on legacy devices – Initial thoughts

On October 20^th 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).

MDCG Medical Device Directive

October 22, 2021

Qserve Welcomes Patrícia da Silva Peres

Qserve Group is pleased to announce that Patrícia da Silva Peres has joined our team to further expand its capabilities in supporting the medical device & IVD industries worldwide.

IVDR MDR 2017/745 Quality Assurance Regulatory Affairs

October 21, 2021

Free Webinar PPT Downloand | MDSAP Mock Audits - Prepare yourself with practising for predictable compliance

October 21, 2021

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

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.

MDCG Medical Device Regulations

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