Medical Device Consulting Services
A complete suite of regulatory affairs, quality, and product development consulting services to support your medical device from concept to global market.
Regulatory Affairs Consulting for Medical Devices
Expert guidance to navigate the complex global regulatory landscape, including FDA 510k consulting and EU MDR compliance, to achieve timely market access.
- Global Regulatory Strategy & Planning
- FDA 510(k), De Novo, PMA, IDE Submissions
- EU MDR / IVDR Compliance Consulting & Transition Support
- Technical File & Design Dossier Remediation
- Health Canada, TGA, ANVISA, UK-MHRA Submissions
- Regulatory Intelligence & Landscape Analysis
- Post-market Surveillance (PMS) & Vigilance Reporting