#iso14155documents

ISO 14155 Documentation are essential to ensuring that clinical investigations of medical devices are ethically conducted, scientifically valid, and regulatory compliant. By maintaining comprehensive records in these ISO 14155 documents organizations can safeguard participant safety, enhance data integrity, and streamline regulatory approvals, ultimately supporting the development of safe and effective medical devices.

The general specifications and requirements for clinical research of medical devices are outlined in ISO 14155:2020. The most recent edition of the standard, which was released in 2020, was created to act as a manual for clinical research specialists when planning, carrying out, documenting, and reporting clinical trials about the security and efficiency of medical devices.