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Highlights

September 01, 2021

QMS and certification requirements for importers and distributors (Article 16)

If you are an importer or a distributor, and you translate any part of the labeling or change the packaging of a device, your life will be much harder under the MDR jurisdiction.

Medical Device Regulations QMS

August 02, 2021

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

Results

September 16, 2021

Myriam Peeters joins Qserve

Qserve Group is pleased to announce that Myriam Peeters has joined our team to further expand her capabilities in supporting the medical device industries worldwide.

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

September 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 Quality Quality Assurance Regulatory Affairs

September 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 Quality Regulatory Affairs Regulatory Compliance Risk Management

September 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 Quality Assurance Regulatory Affairs Software

September 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 Quality

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