As a manufacturer or distributor of medical devices you are confronted with several regulations.
Thewa Innovation prepares and submits compliance documents on your behalf, which will allow smooth certification and introduction of medical devices into the EU-wide market.
Thewa Innovation supplies the following services:
- Analysing available product data and identifying gaps,
- Preparing a technical file and submitting it to the relevant authorities,
- On your behalf, managing communication with the notified body,
- Keeping an eye on the market and on handling any complaints,
- Product documentation is a living document, we take care of updates
Our customers benefit from our professionalism and efficiency, which allows them to focus on income generating activities whereas we take care of the regulatory side.