The Technical Documentation
Manufacturers are legally obliged to demonstrate compliance with the essential requirements specified in the MDR /IVDR. This proof is demonstrated in the technical documentation (TD) and is thus the prerequisite for the approval of medical devices. The documentation covers the design, the manufacturing and intended use of the product and is maintained 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 Body and the manufacturer are committed to a smooth TD assessment process. A well-designed TD is key to a certification.
Our Offer & Support
Leverage the knowledge of Kalms Regulatory Team to help create your Technical Documentation, either complete documentation or specific parts, such as the risk file according to EN ISO 14971. Whether it be document compilation, reviewing existing documentation, performing gap-analyses for the conversion of MDD/IVDD to MDR/IVDR, or guiding you along the way right up until the submission to the Notified Body, Kalms Regulatory Team is ready to support your needs.