FDA Regulatory Clearances
Progressive partners in achieving FDA regulatory clearances for domestic and global companies.
Specializing in Diagnostic Devices:
- Strategic Approaches to Compliance
- CLIA WAIVER Submissions
- 510(k) and PMA Submissions
- Quality Systems
- Facility GMP Audits
- Technical Affairs
FDA and Medical Industry
We facilitate FDA relations with the medical device industry, providing in-roads to US healthcare markets.
We provide expert guidance through the total product life cycle:
- Design and Development
- FDA Submission
- Post-Market Issues
- Risk Management
How to Get FDA Approvals
Download our presentation on managing regulatory issues and getting FDA approvals.