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Specialist’s insight – How to tackle the changes within the transition periods of regulations?

Manufacturers who have devices CE Marked to the directives MDD, AIMDD or IVDD (i.e., legacy devices) have deadlines for regulatory compliance if they want to keep their devices on the European...

The expansion of clinical evaluation has increased the need for clinical competence in companies designing medical devices

The new MDR regulation has expanded the need for clinical evaluation in companies designing medical devices. The interview for my master's thesis highlighted the requirements set by the new...

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