Technical documentation
Build Regulatory Evidence Into a Reviewable Technical File
Organise device information, safety evidence and lifecycle documentation into a clear MDR documentation structure.
Technical documentation is a living regulatory record
MDR technical documentation should clearly describe the device, intended purpose, design, manufacture, verification, validation and evidence supporting conformity.
Typical documentation areas
- Device description and specification.
- Information supplied by the manufacturer.
- Design and manufacturing information.
- General Safety and Performance Requirements.
- Benefit-risk and risk management.
- Verification and validation evidence.
- Clinical evaluation documentation.
- Post-market surveillance documentation.