Regulatory Affairs Regulatory Services Development of regulatory plans, strategies and analyses from concept to approval.  Due diligence of regulatory and clinical documentation. Development of regulatory submissions including: 510(k)s PMAAs IDE's HDE's International applications for clinical trials, including Clinical Protocols and Investigator Brochures Export Approval Applications Design Dossiers and Technical Files for CE Mark

Quality Systems Quality Services Development and review of labeling and advertising materials. Design, Development and Implementation of Quality Management Systems in compliance with ISO 13485 and the FDA's Quality System Regulation and 21CFR, Part 820. Quality System training, audits and audit program implementation. Facility Registration and Device Listing