Services

Cogentsee offers medical device industry, innovators and leaders a robust, strategic and worldwide approach to meeting their regulatory , compliance , quality assurance and project management needs. Our clients stand out in the marketplace, and trailblaze into emerging markets while advancing their goals in preparation for that next great chapter.

Services offered include, but are not limited to:

Submissions

• 510(k)
• International Registrations
• Dossier Compilation 
• Tech Presentations to IRB
• Device & Plant Master File Creation
• CE Marking 
• Global Market Analysis
• PMA
• Product Reclassification

Compliance

• EU MDR 2017/745 
• Tech File Management
• Device Listing Updates
• Establishment Registration
• State Registration
• Field Action Management
• Gap Assessments
• Marketing & Labeling Review
• UDI
• Post Market Surveillance Support
• License & Registration Renewals

Mergers & Acquisitions

• RA System Integration
• Registration & Licensing Transfers

Quality Services

• Audit Support:

- FDA - BSI - ANVISA

- TUV - MDSAP - Findings Response

• Manufacturing Site & Supplier Management
• QMS Support