Regulatory Medical Device Industry

Quality that exceeds regulatory requirements

When you’re designing and developing medical devices, adhering to FDA regulatory requirements is crucial. One small error during the FDA classification and approval submission process could set you back to square one wasting precious time and money. With more than 30 years of experience in quality systems and regulatory affairs services,  you can rest assured that Synectic has the experience and procedures in place to handle your medical device design and development. Synectic can help you develop your regulatory and testing strategy for your medical device. 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.

Whether your path to market is a shortened 510(k) or the full premarket approval process we have the capabilities necessary to guide you through the process. Our medical device engineers have experience designing all classes of medical devices including highly regulated class III cardiac medical devices. Additionally, our quality documentation system is designed to meet or exceed all FDA documentation requirements so you can have peace of mind that everything will be ready for the classification and approval process.

If you are looking for help with the patent process for your medical device then visit our patent page for information on how to get a patent and other frequently asked patent questions.

 

Medical Device Regulatory Industry Capabilities

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

FDA Classification and Regulation

Unsure how the FDA classifies your medical device?
Check out our Medical Device Regulations Infographic below for more information on how the FDA regulates and classifies medical devices.
Infographic about how the FDA classifies and regulates medical devices