For an idea to become a medical device,
it must withstand the many rigors of regulation across global markets.
At Blue Slate, we have fostered a great understanding of regulatory and compliance systems across the world. That knowledge facilitates us to better implement a comprehensive approach that meets the varying requirements of regulatory bodies in different markets, all while accounting for potential risks and navigating challenges as they arise. Our expert guidance, will not only provide you real insights before challenges occur but offer real-time solutions to better support your product launch.
Regulatory Consulting Services Offered:
- Classification Review
- Class III: PMA Review
- Class II: 510k Development
- CE Mark
- Chinese Medical Device Registration (CFDA)