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August 15, 2018

Are you fully trained for the new regulations?

The implementation of the MDR presents many new challenges to medical device manufacturers. As a response to the new Medical Device Regulation introduced by the EU in 2017, Qserve designed a series of trainings which focus on the fundamentals of the new MDR. These valuable training courses only touched on the fundamentals of the EU-MDR. 
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July 30, 2018

Qserve Spotlight on Lorry Weaver Huffman, US Regulatory Team Member

Interview with Qserve's Principal Consultant Regulatory Affairs, Lorry Weaver Huffman
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July 24, 2018

Simplified Approval Process on the Horizon in China – Update on MDR Order 650

On the 25th of June 2018, the Chinese Ministry of Justice published a new version of the Chinese Medical Device Regulation Order 650. The new regulation order is open for comments before final approval. This is the 2nd amendment, a follow-up to the 1st amendment released in late 2017.
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July 17, 2018

Hazardous Substances under the MDR

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July 10, 2018

Qserve Spotlight on Aibang Yuan

Interview with Qserve's Consultant Aibang Yuan
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