What is ISO 20916 - Clinical performance studies of In vitro diagnostic (IVD) medical devices about?
ISO 20916 discusses In vitro diagnostic (IVD) medical devices. ISO 20916 is an international standard on clinical performance studies of In vitro diagnostic medical devices.
ISO 20916 outlines good study practice for the planning, design, conduct, recording, and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
ISO 20916 identifies the principles that underpin clinical performance studies and specifies general requirements intended to:
Ensure the conduct of the clinical performance study that led to reliable and robust study results
Define the responsibilities of the sponsor and principal investigator
Assist sponsors, clinical research organizations, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of In-vitro medical devices
Protect the rights, safety, dignity, and well-being of...