Regulatory Affairs

Regulatory Affairs

Design and Development Documentation

The maintenance of the Design and Development Documentation is often neglected. Choosing the right strategy is crucial!

Development Documentation - What is it anyway?

As the name suggests, the Development Documentation should prove the compliant development of the Medical Device and contain all evaluations of design changes made. Thus, the Development Documentation contains all evidence that confirms that your products meet the requirements of the MDR or other regulations regarding safety and performance.

The Development Documentation is compiled in the development file, which is based on the specifications of EN ISO 13485 and the requirements for the Design History File (US FDA).

It is always the same, isn’t it?

During the audit, the question arises for the Design and development documentation. “Show me the development file for product XY.“

The product has been on the market for what feels like 50 years. Back in 1995, when it was developed, nobody thought about development files. It was documented, but a developer also knows what he is doing, so a few things must have been written on notepads and such.

Should you document the development retrospectively? And should you do that for all the products which have already been placed on the market?

And what about the whole outdated documentation? Some files do exist. But they don't pass the requirements of the EN ISO 13485.

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

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qtec as your partner

Often, a completed development, which took place many years ago, is not documented afterward.

Nevertheless, the requirement of the development file remains valid for "old products", as these are usually also subject to changes, i.e FURTHER DEVELOPMENTS. This documentation also represents a Development Documentation, which now of course has to be stored in conformity with standards and, above all, in a structured manner.

The best strategy here is the one with the least effort, this depends on:

  • Portfolio of products
  • Already existing documents
  • Dynamics of product development
  • Manufacturer's document management system

Therefore we are prepared to work closely with you to develop this strategy so that we can combine the least possible effort with the greatest possible benefit for you.

We have a solution: The qtec Aktenfuchs!

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