Medical Devices and in-vitro diagnostic Medical Devices (IVDs)

Fast and successful access to your key markets

As an independent globally operating consultancy, knoell's international team of more than 20 medical device experts includes specialists in biomedical engineering, software engineering, medical sciences and medical writing, pharmacology, toxicology, chemistry and biochemistry.

We support manufacturers of medical devices and IVDs with our extensive expertise at every point of the product life cycle. Our medical device experts support you in gaining access to global key markets like Europe, North & South America and Asia.

Together with our clients we build a sound market access strategy by identifying the most efficient route to place your products on the desired market.


You are looking for support with design, risk or usability documentation, for advice regarding biological or clinical safety or your quality management topics? At knoell, you will find all this - support from a single source.


Strengthen your know-how

Additionally we provide advanced trainings on:

  • Regulatory requirements for product registration in global key markets (Europe, Asia, North & South America)
  • FDA inspections
  • Strategies to get hands-on experience for conducting biological evaluations (10993-series, biological safety assessments, toxicological risk assessments), clinical evaluations of medical devices (MEDDEV 2.7.1 Rev 4, 2017/745) and IVDs (2017/746).

To view our complete training schedule please check our knoell academy portfolio.


Dr. med. Isabelle Lang-Zwosta Global Regulatory Affairs and Business Development Medical Devices
+1 615 374 1242 send mail

A global network for medical devices

Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!