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Qserve / Axon EU MDR and IVDR pop-up conference in Boston MA on 18 July

Qserve Group and Axon Lawyers (my law firm) are organizing a pop-up mini conference about the new EU Medical Devices (MDR) and IVD Regulations (IVDR) at Qserve’s Boston MA office in the…

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PRRC guidance under MDR and IVDR published

The MDCG has just published its guidance on the PRRC, MDCG 2019-7 “Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person…

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Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices…

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