CE Approvals

We managed the CE approval and ongoing compliance processes for a medical product sold world-wide

American Medical device manufacturers planning to sell products in Europe, Canada, Australia, and many other countries must comply with international regulations such as ISO 13485, European MDD, Canadian MDR, etc. to legally market a product in foreign countries. These regulations require initial approval to begin marketing, as well as ongoing surveillance by the appropriate regulatory agency. The products must obtain initial approval before marketing can begin. But the regulations also require that the manufacturer implement and maintain a Quality System that specifies how the company operates and documents many facets of its operations.

This quality system must demonstrate regulatory compliance in areas such as new product R & D processes, purchasing requirements, manufacturing procedures, adequate and competent personnel, internal audits, regular management reviews, contract sales processes, etc. This can be a daunting task for new medical device manufacturers. Further, the company must be prepared for audits by approved auditors. STI has years of experience with international approvals, quality system regulation, and external audits, and can help you navigate international regulatory processes, so please contact us today!