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.
If 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.
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
The product file must be updated continuously with market observation 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 market observation processes to maintaining your technical documentation: We are happy to support you!
Facing challenges with a smile
True, the requirements for you as a manufacturer are enormous: The EU agrees on a new medical device regulation (MDR) in nearly no time and leaves manufacturers with an interim period of no more than three years to lift all medical devices to MDR level. MEDDEV 2.7/1 revision 4 increases the planning pressure on manufacturers: The notified bodies call for updated clinical evaluation already. And the ideas for software as a medical device often seem to be well ahead of its documentation. Knowing that there is a partner at your side with comprehensive know-how and many years of experience with the documentation and approval of medical devices and IVDs along with their verification and validation, there is no need to worry. We are committed consultants and service providers. Together we make your project a success.We look forward to getting to know you!