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)
- 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 (see link below).