Design and development of medical devices is a major area of focus for Syprosoft® Engineering. We have worked on products covering nearly all of the medical specialties. For details, click on the buttons shown.
MEDICAL DEVICE Regulations
Medical devices are regulated by the FDA based on patient risk. The higher the risk the greater the mandates. Class I devices need to comply with general controls including registration, listing, labelling & good manufacturing practices. Class II devices are subject to special controls including performance, guidelines, pre-market data and surveillance. Class III devices require pre-market approval (PMA) by the FDA.
Regulatory clearance is obtaining permission for new product sales. Syprosoft® Engineering guides clients in navigating the clearance pathway. For high risk devices a cumbersome PMA may be needed. At the other end, some devices are exempt from any filing. The majority fall in between. If the client’s device can be shown to be “substantially equivalent” to a previously cleared device (“predicate”) then a relatively simple traditional 510(k) applies. If no predicate exists a more complex de novo process applies. Note that “substantially equivalent” is not the same as “significantly equal”. This is an opportunity to diminish the claims for the new product to make it substantially equivalent to a predicate. Once clearance is obtained the client may be able to use its own product as a predicate to expand the claims via a special 510(k).
Regulatory compliance is adherence to an quality system. For new products, this includes planning, risk management, requirements, specifications, design descriptions, design output, verification and validation. Syprosoft® Engineering helps clients comply with the latest regulations. We put together systems that are customized to the client’s operations and add only minimal burdens. We design processes that are not only compliant with the regulations but also appropriate to the size of the client thus minimizing compliance costs.