First of all, the technical documentation is to establish proof that all regulatory requirements for market access are adhered to. In Europe this means adherence to the essential requirements according to Annex I of the IVDD and, from May 2022 on, to the essential safety and performance requirements according to Annex I of the IVDR.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 last not least: If preparation of the documentation is well interlinked with the product development process, the safety and predictability of your development process benefit tremendously.
The new classification rules imply increased regulation by the notified body. Considering the tight timing, the revision of your technical documentation requires well structured and clever planning.Contact us
Functional and requirement specifications form the basis for your verification planning – and then you kill all birds with one stone!
... you get an overview of verification measures to be implemented and are able to plan the schedule more efficiently.... you are provided with the information about which and how many test samples you need to be able to implement all verification measures at an early stage.
... With a timely verification plan, 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..... you are provided with the information about which and how many test samples you need to be able to implement all verification measures at an early stage.
According to IVDR, the classification rules are to be applied to the classification of in vitro diagnostic medical devices just as for medical devices. Depending on the IVD classification, different requirements must be met in terms of the conformity assessment procedure and an involvement of the notified body.More about IVDR
Clear, organized, readily searchable and unambiguous
All product files must be updated continuously with post-market surveillance (PMS) results throughout the entire life cycle. Also the effects of changes to the device or manufacturing processes must be documented accordingly. The technical documentation therefore is a living document that needs to be maintained continuously. If your technical documentation is well structured and searchable, you will facilitate its maintenance and save a lot of time in the long run. The IVDR therefore also explicitly requires that “the technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unambiguous manner.”From developing and optimizing your market observation processes to maintaining your technical documentation: We are happy to support you!
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