Mobius Medical provides assistance to client companies with the implementation and maintenance of the post-market activities required by regulatory authorities. Companies must hold, and make available on request by regulatory authorities, the technical documentation that demonstrates the conformity of their products and evidence that an appropriate conformity assessment procedure has been applied.
There are generally three (3) major components of post-marketing activities:
- The manufacturer’s post-marketing surveillance system,
- Post-marketing monitoring of market compliance by regulatory authorities, and
- Vigilance programs.
Mobius Medical is able to assist with all of these activities.