EXPERTISE ACROSS A WIDE VARIETY OF MEDICAL DEVICES

RegChoice Medical Device Services

Medical Devices

RegChoice has years of experience helping companies of all sizes with the regulatory intricacies and complications that may be associated with medical devices.  We will help you determine the proper regulatory pathway for Class I, II, and III devices.  We can manage and perform the entire process, including early-stage research and interaction with FDA, all the way through final submissions and post-marketing.  Our regulatory scientists have expertise across a wide variety of medical devices in all classes.  RegChoice can guide and perform your regulatory activities at any stage and in any capacity.  We can be just a reviewer, or is often the case, the Doer of your entire regulatory process.

Our company addresses clients’ individual needs with respect to their product(s) in any phase of their life cycle.  Our projects span prescription and non-prescription drugs, Class I, II and III devices and drug/device combinations.  We lead or assist interactions with FDA.  We help develop and execute FDA device submissions for Pre-Subs, IDEs, 510(k)s, the De Novo pathway and PMA product lines.

Some Of Our Experience Includes:

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1-813-358-3303