Medical Devices Regulatory Consulting
Device to Market.
FDA & EU MDR.
Getting a medical device to market means navigating device classification rules, technical documentation requirements, and health authority review — often across multiple regions at once. We help manufacturers manage FDA and EU MDR compliance from strategy through approval.
US + EUPathways
Overview
FDA & EU MDR Expertise
Our regulatory consultants support device classification, technical file preparation, and submission strategy for both US and European pathways.
We help manufacturers build a regulatory strategy that works across multiple markets simultaneously, reducing duplication of effort between FDA and EU MDR requirements.
- Device classification and risk-based guidance
- FDA 510(k) predicate analysis and submission
- CE marking and EU MDR conformity assessment
- SaMD — Software as a Medical Device strategy
What We Deliver
Device Approval Pathways
Classification, documentation and submission strategy for global device markets.
FDA 510(k) Consulting
Predicate device analysis and submission preparation.
FDA PMA Support
Premarket Approval strategy for higher-risk devices.
CE Marking & EU MDR
Technical documentation and conformity assessment support.
Device Classification
Risk-based classification guidance.
SaMD Compliance
Software as a Medical Device regulatory strategy.
2US + EU Pathways
5Global Regions
ISO9001:2015
10+Years of Expertise
Our Approach
One Strategy, Many Markets
A device pathway designed to reduce duplication across FDA and EU MDR.
01
Classify
Risk-based device classification for each target market.
02
Plan
Submission strategy across US and European pathways.
03
Compile
Technical file and documentation preparation.
04
Submit
510(k)/PMA and CE conformity assessment support.
05
Sustain
Post-market and change management planning.
Why Vigilare
A Global Device Strategy
Multi-market device compliance without duplicated effort.
US + EU in Parallel
Strategy that satisfies FDA and EU MDR requirements at once.
Full Device Coverage
Hardware, IVDs and Software as a Medical Device.
Documentation Depth
Technical files built to withstand Notified Body scrutiny.
Strategy to Approval
One accountable team from classification through clearance.
FAQs
Answered. Clearly.
01
How do I get CE marking?
Obtaining CE marking under EU MDR requires classifying the device, compiling technical documentation, completing a conformity assessment (often involving a Notified Body), and demonstrating compliance with MDR requirements.
02
What is FDA 510(k)?
FDA 510(k) is a premarket submission that demonstrates a medical device is substantially equivalent to a legally marketed predicate device, allowing it to enter the US market without full PMA review.
Related Services
Explore the Full Practice
Get device approval support across FDA & EU MDR.
Build one regulatory strategy that clears your device in multiple markets — without duplicated effort.