Navigating the myriad rules and requirements on the manufacture and use of medical devices can be a labyrinth of frustration, given the often-conflicting directives from the various agencies regulating the manufacture and the use of these devices. Countless businesses have substantial delays in the introduction of their product – delays that could have been avoided with a more complete map of the regulatory minefield of medical review boards and government agencies who each have their own set of guidelines.
Bright can give your medical device company the support and guidance you need to win approval of your products. And most importantly, to avoid having those products pulled from market down the road by regulators with oversight in markets entered into during your future expansion. We will provide thorough and cost-effective support through all stages of your device's introduction – from clinical development to regulatory approval to helping you conform to rules and requirement imposed beyond initial approval. We'll help you to successfully:
- Create targeted regulatory strategies
- Conduct Gap Analyses
- Design and execute clinical trials
- Prepare necessary documentation, such as:
- CE Mark submissions
- Design quality systems
- Develop reimbursement strategies
- Meet post-marketing surveillance requirements
- Provide audits of manufacturing facilities and other facilities
Our suite of services will carry you through the entire approval process and meet all requirements set forth by the Medical Device Directives (AIMDD and MDD), and the In Vitro Diagnostics Directive.