Have you faced any delays in the development and approval process of you medical device? Do you know what aspects of biological risks you should think of? Is it mandatory to execute all the tests recommended in the annex of ISO 10993-1?

PRRC candidates are often reluctant to accept the function due to the fear of the consequences this potential liability could incur. This article aims to discuss PRRC qualification requirements and PRRC function, as well as to clarify the legal liability of PRRCs.

ISO 14155:2020 is expected to be harmonized rapidly, but aside from the main documentary changes listed in the foreword of the standard, what are the major changes to be aware of when planning, designing, or conducting a clinical investigation?