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十月 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

十月 14, 2021

IVDR延长宽限期提案——切不可松懈！！！

欧盟委员会已发布关于延长IVDR宽限期安排的提案。这并非简单的单向延期，因此有赢家也有输家。

In-Vitro Diagnostics

结果

十月 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

十月 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 Regulatory Affairs

十月 21, 2021

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

十月 21, 2021

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

十月 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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