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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.
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