Stricter regulatory requirements on medical device economical operators (i.e. manufacturers, distributors, and importers) pose a major challenge to company acquisition processes. Strengthening your Due Diligence team with a Medical Device Quality and Regulatory expert will increase your chances of a successful project. 

Our Due Diligence consultants are ready to support your Due Diligence project from a Quality and Regulatory perspective, either on-site or off-site. We investigate and make comprehensive appraisals of medical device businesses, with your specific business perspective in mind. 

Our offer is an investigation to evaluate the QA/RA maturity of medical device products and quality processes for development and manufacturing thereof, in relation to applicable standards and regulations such as ISO 13485:2016, EU Medical Device Regulation (MDR, 2017/745) and FDA 21 CFR Part 820. 

Contact us for further information

Contact us here if you have any questions or want to learn more about how we can support you.