The approval of medical devices in Europe according to EU MDR 2017/745 or other regulations, e.g. USA according to 21 CFR 820, is a complex process and requires a lot of expertise about the medical device in question, its classification, its life cycle from development, through production, to use and disposal. Approval of a medical device involves a large number of steps and the associated documentation. We help you with all steps of the product approval process. You decide how much help you want to take advantage of and decide on the scale from a simple consulting meeting to the complete takeover of the entire approval process.
STEIN HEALTHCARE PROJECTS
You can receive support from us in all questions relating to the conformity of medical devices in Switzerland, the EU, the MDSAP countries US, CAN, BR, AUS, JP and other countries.
We advise you “Made in Swiss!”