Today's global medical device and in vitro diagnostic companies are increasingly challenged by numerous and frequently changing regulations throughout the world. St. Paul Consulting develops strategies and assists clients in complying with these regulations.
EU Medical Device Directive (MDD) and CE Marking Assistance Meant to simplify and harmonize the many regulations of member countries of the European Union, the Medical Device Directive represents a single path to a market of over 300 million consumers. Beginning in June of 1998, all medical devices marketed in the European Union were required to bear the CE Mark. This Mark is a medical device manufacturer's declaration of full compliance to the MDD. St. Paul Consulting assists clients in navigating the language of the MDD and taking the neccessary steps to assure compliance and apply the CE Mark.
US Quality System Regulation (cGMP) Assistance Since the FDA's new Quality System Regulation(QSR) closely mirrors ISO 9001, St. Paul Consulting is uniquely positioned to add significant value to clients' efforts to become compliant with the QSR. Our consultants have assisted over sixty companies in becoming compliant to ISO 9001 and the FDA's QSR.
Technical File and Design Dossier Assistance One of the most time consuming and complex requirements of the Medical Device Directive is the creation of the technical file or design dossier for product families. St. Paul Consulting has assisted over seventy-five clients in building technical files and design dossiers.
EU In Vitro Diagnostic Directive (IVD) Assistance Similar to the Medical Device Directive, the proposed In Vitro Diagnostic Directive harmonizes the regulatory requirements of member countries of the European Union. Once the IVD is adopted as national law in Europe, in vitro diagnostic products marketed in the EU will be required to carry the CE Mark. St. Paul Consulting helps companies prepare to sell in the European marketplace.
Internal Audits A common requirement of world-wide quality system regulations, internal audits can present a company with significant challenges. In addition to training internal auditors and allocating the resources to perform the audits, companies must find a way to make the internal audit process add value and help improve business processes--not just meet a regulation. St. Paul Consulting assists companies address these challenges with a range of services including internal auditor training, complete quality system and regulatory compliance audits, and corrective action system development.