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.
Risk Management | Software and Cybersecurity | Marketing approval for medical devices, MD and IVD
Clinical evaluation and Performance evaluation | Biocompatibility assessment | Quality Management System for medical device manufacturers
PMS – Post Market Surveillance | Due Diligence | Usability | Acccess the European Union (EU) | Acccess the UK
