ISO 14155:2020

ISO 14155:2020

ISO 14155 is an international standard for Clinical research of medical devices for human subjects – Good Clinical Practice (GCP) and is a certification about clinical trial management standards concerning the design, performance, recording, and reporting of medical devices clinical trials.

Cetas Healthcare is involved in the Post-Market Clinical Follow-up (PMCF) survey and collects clinical data to assess the clinical performance or effectiveness and safety of medical devices. Cetas team is well versed and compliant with ISO 14155:2020 Good clinical practice requirements, and EU Medical Device Regulations, and provides valuable insights and high-quality PMCF data to the medical device manufacturers.