Design and development of medical devices is a major area of focus for Syprosoft Engineering. We have worked on regulatory Class I, II and III products covering nearly all of the medical specialties. For details, click on the buttons above.
Unlike many other products, medical devices are regulated by governmental authorities due to potential risks to patients. They have to be designed and documented in a manner that is compliant with regulations. These processes facilitate FDA filings for product clearances including 510(k) and PMA applications. They also allow CE marking for the products and adherance to regulations in other jurisdictions. The figure below shows the essential elements to global regulatory compliance.