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Faits marquants

septembre 01, 2021

Exigences en matière de SMQ et de certification pour les importateurs et les distributeurs (article 16)

Si vous êtes un importateur ou un distributeur et que vous traduisez une partie de l'étiquetage ou modifiez l'emballage d'un dispositif, votre vie sera beaucoup plus difficile sous la juridiction de la MDR.

Medical Device Regulations QMS

AI is hot this summer. Stand Up, Speak Up

For most of us, it’s time for the summer holidays. When packing your bags, it is always good to have some quality literature with you so you can read your way through the lazy days. Only, this summer for AI medical device manufacturers these rustic days won’t be as rustic anymore, for AI is hot this summer.

AI Regulatory Affairs Highlights

Résultats

septembre 16, 2021

Myriam Peeters a rejoint notre équipe

Le Groupe Qserve a le plaisir d'annoncer que Myriam Peeters a rejoint notre équipe afin de renforcer nos capacités à soutenir les fabricants de dispositifs médicaux du monde entier.

Europe Medical Device Regulations Medical Devices MedTech New colleague Qserve Group Regulatory Affairs Regulatory Compliance

septembre 13, 2021

Olena Hoi joins Qserve

Qserve Group is pleased to announce that Olena Hoi has joined our team as consultant to further expand her capabilities in supporting the medical device industries worldwide.

Audit program Auditing Europe Global Registration Medical Device Regulations Medical Devices New colleague QMS Qserve Group Regulatory Affairs

septembre 10, 2021

Thomas Ostermeier joins Qserve

Qserve Group is pleased to announce that Thomas Ostermeier has joined our team to further expand its capabilities in supporting the medical device industries worldwide.

Clinical Evaluation Europe Germany Market Access Europe Medical Device Regulations Medical Devices MedTech QMS Qserve Group Regulatory Affairs Regulatory Compliance Risk Management

septembre 09, 2021

Paul Hoseit Joins Qserve

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

In-Vitro Diagnostics IVDR MDR 2017/745 Regulatory Affairs Software

septembre 06, 2021

Joshua Spencer joins Qserve

Qserve Group is pleased to announce that Joshua Spencer has joined our team to further expand its capabilities in supporting the medical device and IVD industries worldwide.

Biocompatibility Europe In-Vitro Diagnostics ISO 13485:2016 IVDR Medical Device Regulations Qserve Group

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