Requirements analysis

Medical device regulation covers the entire product lifecycle, from conception to post-market surveillance.

Understanding and implementing regulations requires experience and expertise. We assist you in navigating the complex EU CE marking and US FDA regulations, enabling market access for your devices. Our consultants provide support for risk based pre-market strategies, clinical data, verification and validation, notified body selection and regulatory submissions.

Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me an mail