55
DAYS
28
MAY
2026
DEADLINE

EUDAMED registration
becomes mandatory.

Is your device portfolio ready?

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CONSULTING

Regulatory strategy
& execution

DHF development, QMS implementation, technical file preparation. From gap analysis to Notified Body submission.

  • EU MDR technical documentation
  • ISO 13485 QMS gap analysis
  • Design history file development
  • Risk management (ISO 14971)
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AUTOMATION

Spreadsheet in.
Validated XML out.

Transform your device data into EUDAMED-ready XML submissions. Every field validated against official EC specifications.

XSD 3.0.28schema validated
90+ rulesbusiness logic
Bulk processingentire portfolio
Export readyXML output
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VALIDATED AGAINST OFFICIAL EC SOURCE DOCUMENTS
Data Dictionaryv2.25.0
Business Rulesv1.0
XSD Schemav3.0.28
Enumerationsv1.1

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Or email directly: contact@bridgemedtech.com

I'm Nishant — a regulatory consultant who builds software. After 20 years helping medical device companies navigate MDR, FDA, and ISO frameworks, I started automating the repetitive parts. Bridge Medtech is where domain expertise meets practical tooling.

EU MDR 2017/745 ISO 13485 FDA 21 CFR 820 ISO 14971