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Medical Devices Regulation (MDR)
Technical Documentation File
The Technical Documentation is a file required to demonstrate compliance of the device with the General Safety and Performance Requirements of the MDR / IVDR. The preparation of the technical documentation, including developing and writing the required supporting documents, demands specific expertise and allocation of extra resources, which can become an overwhelming task for manufacturers.
BioTop Medical has the expertise and the resources to help you with this task. We are able to:
- Organize the Design History File (DHF)
- Draft and/or review DHF documents; output documents from the several phases of development (plans, reports)
- Organize and/or review Device Master Records (DMR)
- Coordinate device risk management (including usability risk management) and/or write risk management plan, report
- Write or review biological safety assessment plan and report
- Write or review usability engineering – related plans and reports
- Write (IVD) device clinical or performance evaluation plan and report
- Perform systematic, unbiased literature searches
- Document, perform the post-market surveillance activities
We write the technical documentation in accordance with the requirements of Regulation EU 2017/745 ‘MDR’ (Annexes II and III) and by the Regulation EU 2017/746 ‘IVDR’, (Annexes II and III).