Our extensive regulatory compliance expertise and lean ISO-13485:2016 certified processes help drive your medical product to a successful, first-time submission. We know what the FDA and international agencies look for and tailor the effort to your needs.

Here are some of the Quality services we provide:

• Authoring, contributing, and maintaining design history files
• V&V Planning to essential requirements and medical safety standards including protocol development, Ad Hoc testing, Unit Testing, Formal Verification, Verification Reports, and Coverage Reports.
• Navigating regulatory bodies including requirements review and regulatory strategy support (IEC-14971, IEC-62304, IEC-62366)
• Working with you directly to provide the right compliance information for your FDA submittal including 510(k) Clearance for a Class II device, a Pre-market Approval (PMA) for a Class III device, or a de Novo 510(k)
• Planning and strategizing the test plans and protocols for all disciplines including electrical, mechanical, software, usability, and systems; create, execute, and provide reports
• Defining systems and software to ensure the most rigorous treatment is limited to the safety-critical code
• Performing Gap Analyses for IEC-60601-1 for medical electronics, IEC-62304 for medical software, IEC 62366 for usability, IEC 61010-1 Safety Requirements for Electrical Equipment and other standards where needed
• Medical device quality assurance, medical device validation, and medical device compliance management