Regulatory and Compliance Services

Verification and Validation

We have extensive experience in Software Verification and Validation having performed V&V on over 50 medical devices, including several Class III medical devices. Types of activities performed for V&V include: code inspections, code walkthroughs, unit (module) testing, integration testing, requirements testing, and traceability. Aubrey Group also uses the expertise of Noblitt and Rueland, a consulting company specializing in technical FDA & international regulatory issues, including software V&V, to provide independent validation services.

We have developed a rigorous process for software V&V and have completed software V&V on more than 50 medical devices. Many of these medical devices perform critical procedures on patients. FDA has found our software and software V&V to be acceptable for all our products that have been submitted so far.

Safety and Regulatory Compliance

We are registered with the FDA as a Medical Device Establishment and are licensed by the California Food and Drug Branch for the design and manufacturing of medical devices. Our Quality System complies with the ISO 13485-2003 standard.

We can help you setup your quality and compliance policies, procedures and systems.