Regulatory Medical Device Industry


When you’re designing medical devices, adhering to regulatory requirements is crucial. With more than 20 years of experience in quality systems and regulatory affairs services, Synectic can help you develop your regulatory and testing strategy for your medical product development.


We work with several partners to handle all your FDA and ISO 13485 regulatory and quality needs and can develop a documented strategy including predicate device identification, classification, testing plan, and a face-to-face meeting with FDA representatives.


Our capabilities include:

  • Extensive knowledge of the patent process
  • Optimizing your design for FDA approval
  • ISO-compliant quality documentation system
  • Knowledge of ISO standards


If you are new to medical device design and development check out our Medical Device Regulations Infographic for more information on how the FDA regulates and classifies medical devices.