ISO 14155 on Clinical investigation of medical devices for human subjects - Good clinical practice

ISO 14155 Certification addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out on human subjects.

ISO 14155 specifies general requirements intended to protect the rights and safety of human subjects to ensure the scientific conduct of the clinical investigation and the credibility of the results.

The purpose of this standard is to define the responsibilities of the sponsor and principal investigator, and assist sponsors, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.b

Benefits of ISO 14155 certification:

  • protection of human subjects
  • assurance of reliable conduct during the course of clinical trials
  • conduct of good clinical practice
  • certification of reliability of clinical studies and monitoring reports, monitoring performance, correct performance of research and investigation, ethics committee performance, involvement of regulatory authorities and subjects into assessment of compliance of medical devices.

Certified organisations can promote themselves as certificate holders in their promotional materials and can include the URS certification logo free of charge.

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