Management of and hands-on completion of FDA and Health Canada annual registrations, successful submission of Technical Files for CE Marking, 510(k)’s, Health Canada device registrations, and medical device listings.
Regulatory Information Management (RIM) is becoming extremely important for companies trying to manage regulatory submissions, product registrations, content management and more. We can help you develop the RIM strategy that is right for your company; and then help with its implementation. |
Clinical evaluation reports and assistance with finding the right CRO are also in the services we can provide you.
Continually staying abreast of the ever-changing regulatory environment, helping our partners understand what these changes mean to them. And guiding them as they implement the changes needed to be compliant. |
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