The Technical Documentation
Manufacturers are legally obliged to demonstrate compliance with the essential requirements specified in the MDR /IVDR. This proof is provided by the technical documentation and is thus the prerequisite for the approval of medical devices. The documentation covers the design, manufacturer and intended operation of the product throughout the entire life cycle of the medical device (including Post-Market Surveillance).
With the exception of MD class I or IVD class A medical devices, manufacturers must submit the technical documentation to a Notified Body for review and certification. Both the Notified Bodies and the manufacturers are committed to a smooth TD assessment process, so a well-designed TD is key.
Let Kalms Regulatory team help you with the creation of your Technical Documentation, whether with the complete documentation or parts thereof, such as the risk file according to EN ISO 14971. We support you with the compilation, review of your existing documentation, offer gap analyses from the conversion from MDD/IVDD to MDR/IVDR and accompany you during the entire process up to submission to the Notified Bodies.