510(k) Submission
Introduction
Radiographic Dental Imagery Device – Class IIb
Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe.
Following European success, our client set their sights on the US market.
Standards & Tools
- FDA
- 21 CFR Part 820
- GDPR
- Word Excel, Powerpoint
Scope of work
Review of documentation for applicable FDA recognised standards for this product range
Preparation of the full 510(k) premarket notification submission (including comprehensive acceptance checklist for a timely acceptance of submission)
Identification of predicate devices
Provision of timely and expert support in response to FDA requests for additional information
Key numbers
Team
1 FTE
Location
Italy
Length
4 weeks
Type
Work Package
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