ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice is now officially published !

The revised standard introduces various new requirements in an effort to establish a risk-based clinical investigation process and therefore take a step closer to harmonization with the new Medical Device Regulations.

The new Standard will also have a significant impact on PMCFactivities and studies related to EU-MDR. We have summarized the major revisions in this document. Download it here

Access/Purchase the new Standard here: ISO14155:2020

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