Can Do Medical
 
 
Confidently steering you clear of compliance issues

Can Do Medical offers our Strategic Complaints and Reporting service at two levels depending on your needs. Whether you require assistance simply understanding the FDA's MDR rules, or need a global solution to your reporting problems worldwide, we have the service for you.

If your goal is to maintain control of the complaints and reporting process, but not to run the risk of mishandled adverse event reporting, we will augment your staff with one of our regulatory experts. With this approach, we can help you evaluate complaints and determine if they are reportable to any or all of the markets you are in. We can also review or write the reports so that they are compliant and make good business sense.

Additionally, USA reports are required to contain information which then becomes accessible anywhere in the world, and all your adverse events must be reported regardless of what country they occurred in. Furthermore, all files must be in English
and accessible from the USA . It is unwise to compose these reports without the help
of a regulatory expert who knows how to control the release of information.
Our service keeps your risks under control.

  • The FDA requires more compliance reporting than anywhere else in the world
  • We offer various levels of service to help you control risk most effectively
  • Our trusted regulatory experts can guide you at every level