Technical documentation: your ticket to the medical technology market

A medical device always consists of the medical appliance AND its product file. Regardless of the device classification, whether you want to launch a class I, IIa, IIb, or III medical device or in vitro diagnostics: You must provide technical documentation in any case.

The technical documentation includes all details about the medical device. In addition to the actual technical product information, it also includes all specifications about development, manufacturing, verification and validation, as well as application of the product.

By means of the technical documentation, you as the manufacturer establish proof that your medical device conforms to the underlying regulations of the individual countries. Furthermore, it confirms compliance with the basic requirements for European CE marking. It is the prerequisite for the approval of a device in the relevant target country. Across the entire lifecycle of the device, but at least five years after the last device’s manufacture (15 years for implants), the technical documentation must be available to the supervisory authorities for inspection.


Do not lose sight of your target!

Already while creating the technical documentation you should take into account possibly different requirements of different target markets. That way documents and their contents may be developed and structured in a way that they may be used for as many submissions as possible.

Commission us to provide the documentation and we will start working on it promptly. We hardly need any time to familiarize ourselves with the topic, because we are already familiar with it. With our wide range of expertise, we know the regulatory requirements back to front and make sure that they are adhered to in your documentation. The result: finalized documents ready to be signed using your templates.

Medical engineers, computer scientists, physicists, and biologists: We are experts and all-rounders – and for sure exactly what you need.
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Our services in detail

Fit for the future with the Metecon Academy

Each of our workshops and in-house courses provides sustainable knowledge and know-how in the areas of technical documentation, regulatory affairs and QM and is always exactly tailored to your needs.

Our customers use our workshops with our experts:
to keep themselves and their team up to date with the latest knowledge and/or to go into intensive exchange with us and gain clarity in the face of a current challenge about a specific description of objectives and the project strategy.

Through the operation of our own trainee academy, our comprehensive training material is always up to date.

Let us find out together what your team needs!

Workshop topics:

  • Implementation of IVDR for technical documentation and QM
  • Risk management
  • Usability
  • Biological safety
  • Clinical affairs
  • Software
  • Approval
  • Quality management

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