In vitro diagnostic medical devices (IVDs): Conformity for safety

In vitro diagnostics (IVD) are the specialists among medical devices: complex and effective. Due to their distinctive characteristics, IVDs are regulated separately in the in vitro diagnostic regulation (IVDR). The efficient interaction of different quality management processes is to ensure safe and effective devices that remain safe and effective throughout their entire lifecycle.

With the technical documentation you prove against third parties that these processes are conducted in a correct manner and conform to the respective target country.

We help you on all levels and at any given time in the product lifecycle to fulfill this requirement.

Get to know us

IVD or medical device?

Any IVD is of course a medical device. However, as in vitro diagnostic medical devices take on a special role among medical devices and are regulated separately (IVDR), we have also decided to treat them separately.
We hope that it makes as much sense to you as it does to us.

Our Services at a Glance

We offer the following services to support you:

Developing and maintaining the technical documentation:
  • Creating the content of the technical documentation (EU and international) – conforming to applicable standards and laws,
  • Checking the technical documentation of IVDs already available on the market against current regulatory requirements,
  • Communicating with notified bodies and test laboratories.

Revising and adapting quality management:
  • Analyzing the need for changes,
  • Adapting the processes.

Other services:
  • Risk management process in accordance with ISO 14971,
  • Software development process in accordance with IEC 62304,
  • Verification and performance evaluation,
  • Validation of production and test equipment.

Your advantages when working with us

  • We are your reliable partner for adapting your QM processes and developing and revising the technical documentation of your IVD.
  • You receive all documents for your technical documentation based on your templates and ready to be signed for approval (international) or product certification (EU).

  • Our experience with technical documentation and the certification process as well as with verification and validation of IVDs and medical devices ensures that we reach your goals quickly and efficiently.
  • Our GAP analyses deliver recommendations on all levels of your regulatory activities (QM system, technical documentation, product portfolio).

Keep track of everything: Your IVDR schedule


Between directive (IVDD) and regulation (IVDR): What do you need to do?

UDI, EUDAMED, software, classification, shortfall of notified bodies: These are some keywords in the current discussion and in view of the IVDR taking effect the major obstacles that manufacturers have to overcome.
In addition, these issues are interdependent, i.e. the results of risk management influence software development, UDI requirements affect labeling processes, post-market surveillance needs must be represented in the QMS – regulatory is teamwork!
A transition period of five years sounds like a lot of time. But let’s do some simple math together: Assuming there are 50 product files and you need only 200 hours each for revision, you end up with a total of 10,000 hours – more than one person can handle in five years.

You need support? We look forward to contributing to your team success.

Everything planned already?

Especially the new classification rules and the resulting increase in regulation through the notified body confront manufacturers with tremendous challenges. Considering the defined timelines, you need a solid and elaborate plan how to revise the technical documentation.
Contact us


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

Ihre Nachricht an uns