Product Overview
Consulting Services for the Medical Device Industry
What We Offer:
- Regulatory strategies
- 510(k)s
- IDEs
- PMAs
- De Novo submissions
- Combination products
- Requests for Designation
- Letters to File
- Master File development and submissions
- FOI Requests
- Breakthrough Technology applications
- STeP applications
- Pre-Sub / Q-Sub applications
- Clinical literature article review / editing for publication
- FDA User Fee and Small Business applications
- Establishment registrations
- Device listings
- Certificates to Foreign Governments (CFGs)
- Strategic and tactical consulting
- Review of device labeling, package inserts, user manuals, web sites, videos, and marketing literature for regulatory compliance, clarity, and market advantage
- Import/Export issues
- Canadian Device License Applications and Amendments
- EU Technical Files, Declarations of Conformity
- MDR / IVDR Compliance
- Australian registrations
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