Regulatory Affairs
Before marketing a medical device in the US, or reintroducing a device that has been modified affecting safety or effectiveness, medical device manufacturers need to submit to the Federal Drug Administration (FDA) a premarket notification or 510(k) and demonstrate by testing and documentation that it is substantially equivalent to an already marketed device and that no new safety or effectiveness concerns are introduced.
Smestad & Associates provides complete regulatory consulting services for 510(k) submissions, as well as other medical device regulatory affairs needs, such as the Medical Device Directive (MDD) CE marking, Health Canada licensing or FDA Quality Systems Regulation (QSR - 21 CFR 820) compliance. Our team can efficiently help you achieve product clearance.