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Project Scope & Proposal Request

Please provide details on your device classification and manufacturing status so we can build an accurate regulatory roadmap.

Initial Client Questionnaire

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1. Company Information

VigilaMed

Regulatory Excellence for Device Manufacturers. Elite Quality & Regulatory consultancy specializing in ISO 13485, FDA compliance, and medical device manufacturing excellence.

ISO 13485:2016 Lead AuditorFDA 21 CFR Part 820 ExpertSix Sigma Yellow Belt10+ Years Manufacturing

© 2026 VigilaMed Ltd. All rights reserved. Serving Class I, II, and III device manufacturers across UK, EU, and US markets.