Medical device technical file
A medical device technical file is a comprehensive document that contains all the technical information and data related to a medical device, such as design, manufacturing, testing, clinical evaluation, and risk management. It is an essential part of the medical device conformity assessment process, and it demonstrates the device's compliance with applicable regulatory requirements, such as the European Medical Device Regulation (MDR) or the US Food and Drug Administration (FDA) regulations.
The technical file typically includes detailed information on the device's intended use, technical specifications, components, materials, manufacturing processes, sterilization, packaging, labelling, and instructions for use.
How can a CCMS help?
- It can help manage large amounts of structured content that is required for regulatory compliance.
- It can centralize content for stakeholder accessibility and collaboration.
- It can facilitate translation and localization of medical device technical files, ensuring all versions are consistent accurate.