Regulatory Filings

US Filings

US 510(k) Submission

Establishment Registration

FDA Export Certificates

California Medical Device Manufacturing License

Health Canada Filings

Medical Device License

Health Canada Registration

EU Files

Technical File constructions for CE Marking

CE Design Dossiers
   Beyond Quality & Compliance
Regulatory Filings
Our services are
founded on the
following tenets:  
due diligence,
integrity, and a
passion for
Value added creative solutions for your business