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:

  • Concept
  • Feasibility
  • Design and Development
  • FDA Submission
  • Manufacturing
  • Validation
  • Post-Market Issues
  • Risk Management

How to Get FDA Approvals

Download our presentation on managing regulatory issues and getting FDA approvals.