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 or if you want to learn more about how we can support you.

Stockholm Office Färögatan 33, 164 51 Kista, Sweden.
Lund Office Scheelevägen 17, 223 70 Lund, Sweden.

+46 8 621 01 05

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