FDA Classification and Regulation
Unsure how the FDA classifies your medical device? Check out our infographic below for more information on how the FDA regulates and classifies medical devices.
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Quality standards you can count on
Exceptional quality standards
When you’re designing 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. Synectic 40 years of experience in quality systems and regulatory compliance. When you work with us you have peace of mind that we have the experience and procedures in place to handle your quality and regulatory compliance requirements. Synectic can help you develop your regulatory and testing strategy for your device. We work with several partners to handle all your FDA and ISO 13485 regulatory and quality needs. Together we develop a documented strategy including predicate device identification, classification, testing plan, and a face-to-face meeting with FDA representatives.
FDA focused process
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 implants. With our NPI area available to de-risk your assembly and manufacturing processes, you can mitigate any potential risks before the FDA approval process. 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.
Dependable regulatory compliance
We have the knowledge and experience working within industry and regulatory standards to get your device to market. Our capabilities include:
- Extensive knowledge of the patent process
- Designs optimized for FDA approval
- ISO certified quality documentation system
- Knowledge of ISO standards