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FDA Registration * FDA Compliance * Premarket Notification 510(k) * ISO 13485 * CE Mark
Regulatory Insight * Specializing in FDA Registration & FDA Compliance. FDA and Medical Device Consulting.
Comprehensive worldwide regulatory consulting services.
FDA PMA Premarket Approval
FDA 510(k) Premarket Clearance
FDA and other regulatory body accepted clinical studies
FDA Establishment Registration and Device Listing
Health Canada Medical Device and Establishment License
European Commission CE mark
Australian TGA Registration
FDA and ISO 13485 Compliant Quality Systems
Employee Regulatory and Quality Systems Training
Assistance with Import and Export Issues
Representation of a U.S. Agent
FDA Registration Consultants * FDA Compliance Consultants * 510(k) Submissions