Article

Question-based development of high-risk medical devices: A proposal for a structured design and review process.

2022-08-09

Abstract excerpt

The recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a higher risk category, thus requiring more data before market approval, and a much larger focus has also been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity. However...

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Literature Corpus work: bb5fbc7a-74f3-5a97-88b1-0dca0e3dce35
DOI: 10.22541/au.166005536.60655842/v1

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