Due Diligence
Not only the financial results that are important when acquiring a medical device company. It is equally important that documentation relating to products and management systems comply with the regulatory requirements. Performing a review of relevant documentation, certificates, registrations, etc., reduces the risk of unpleasant surprises when a potential acquisition has been is completed.
Fjord Consulting examines the management and technical documentation such as Technical Files, Design Dossiers and Design History Files. Validation is performed against relevant regulations and standards as well as your requirements. The results are compiled in a report.