Stricter regulatory requirements on medical device economical operators (i.e. manufacturers, distributors, and importers) poses a major challenge to company acquisitions 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 appraisal of medical device businesses, with your business perspective in mind.
Our offer is an investigation to evaluate 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 me for further information
Office +46 8 621 01 05 or send me a mail