Device Submissions & Registrations
One Device.
Every Market.
Getting a device registered in one market is a project. Getting it registered across multiple markets simultaneously requires coordination, consistency, and a team that knows each region's submission format. We manage device submissions and registrations end-to-end.
End-to-EndTracking
Overview
Global Submission Management
We handle the full submission and registration process — compiling technical documentation, coordinating with regulatory bodies, and tracking submissions through to clearance.
Every submission is built on a foundation of accurate technical documentation and a clear regulatory strategy, reducing the likelihood of agency queries or delays.
- 510(k), PMA and De Novo submission management
- EU technical file and CE marking submissions
- UK and Canada device registrations
- Structured device dossier preparation
What We Deliver
FDA, EU & International
Coordinated submissions and registrations across jurisdictions.
FDA Device Submissions
510(k), PMA, and De Novo submission management.
EU Technical File & CE
Documentation aligned to EU MDR requirements.
UK & Canada Registrations
Market-specific device registration support.
International Registrations
Support for additional global device markets.
Device Dossier Preparation
Structured technical documentation compilation.
4+Markets Managed
5Global Regions
ISO9001:2015
10+Years of Expertise
Our Approach
Compile, Coordinate, Clear
A managed submission pipeline tracked through to clearance.
01
Prepare
Compile accurate technical documentation and dossiers.
02
Strategise
Set a clear, market-specific regulatory strategy.
03
Submit
File through the appropriate regulatory bodies.
04
Track
Coordinate agency interaction and query responses.
05
Clear
Manage the submission through to market clearance.
Why Vigilare
Documentation & Strategy
Fewer queries, fewer delays, one coordinated team.
Accurate Documentation
Submissions built on a foundation of solid technical files.
Multi-Market Coordination
One team managing parallel submissions across regions.
Format Fluency
Each region's specific submission format handled correctly.
Fewer Delays
Clear strategy that reduces agency queries and rework.
FAQs
Answered. Clearly.
01
How do I submit medical devices globally?
Submitting medical devices globally involves preparing region-specific technical documentation, meeting each market's classification and conformity requirements, and filing through the appropriate regulatory body, such as the FDA or an EU Notified Body.
02
What is the device registration process?
The device registration process involves classifying the device, compiling required technical and safety documentation, and submitting it to the relevant health authority for market clearance or approval.
Related Services
Explore the Full Practice
Start your device submission with one coordinated team.
We manage technical documentation, agency coordination, and tracking through to clearance across every market.