Primarily, the technical documentation serves as proof of compliance with regulatory requirements for market access; in Europe, that is compliance with the MDR general safety and performance requirements.However, another aspect is just as important: The technical documentation is an important tool for minimizing risks of liability. Because only if you are able to reproduce properly whether an event on the market is due to a design error or may be limited to a batch, you may launch adequate and reasonably limited measures.And there is yet another aspect about the technical documentation that is often underestimated in our opinion: If the development of the documentation is well interlinked with the product development process, the safety and predictability of the development process benefit tremendously.
Once basic documentation is available, it is rather easily manageable to prepare the application documents required for the target country.
Contact usIf you create the verification plan at an early stage based on the information from the functional and requirement specifications, you kill all birds with one stone:
... You receive direct feedback whether the requirements and specifications are phrased in such manner that they can be tested (the requirement to do this is laid out in chapter 7 of EN ISO 13485).
... You get an overview of verification measures to be implemented and are able to plan the schedule more efficiently.
Classification
According to IVDR, the classification rules are to be applied to the classification of in-vitro diagnostics just as for medical devices. Depending on the classification, different requirements must be met in terms of the conformity assessment procedure and the involvement of the notified body.
More about IVDR
More about IVDR
The product file must be updated continuously with PMS results throughout the entire lifecycle. In addition to the general maintenance of risk management and clinical evaluation, the MDR requirements of the different reports (e.g. PSUR) have to be taken into account as well in the future. Also, the effects of changes to the product, e.g. due to a discontinued component, or to manufacturing processes must be documented accordingly. From developing and optimizing your PMS processes to maintaining your technical documentation: We are happy to support you!