Real results from medical device manufacturers who chose VigilaMed.
“We evaluated six companies, including two we'd worked with before. By the time VigilaMed came to the first meeting, they already knew what we needed and what we didn't.”
— Kenji Watabe, VP Operations, Ovation Medical
“We need consultants we can rely on to deliver at pace and for it to be right the first time around. With VigilaMed, I can quickly scan the work, see that it's compliant, and drop it into place immediately.”
— Joe Hagan-Brown, Principal Consultant & Director, MedRAS
No commitment. 30-minute strategic consultation.
Access our self-paced, inspection-defensible training courses designed by regulatory specialists. Earn your FDA QMSR Internal Auditor Certification with scenario-based assessment and downloadable audit tools.
Select your most pressing challenge. We'll show you exactly how we solve it.
The FDA's new inspection program is live. 56% of inspections are producing 483s.
May 28, 2026. No registration, no EU market access. 49 days remaining.
Already received findings? We remediate under deadline pressure. 34-day turnaround proven.
We understand the stakes. Your compliance isn't just about paperwork — it's about patient safety, market access, and manufacturing efficiency.
From design controls to production floor, we deliver comprehensive QARA support across the entire device lifecycle.
Building and maintaining the core infrastructure.
Preparing for inspections and fixing critical issues.
Ongoing surveillance and specialized roles.
Initial discovery call
Regulatory Roadmap & Strategy
VigilaMed supports you across the entire device lifecycle — from initial concept to ongoing post-market compliance
Real compliance transformations with measurable outcomes. From cardiovascular implants to diagnostic equipment.
FDA Class I — Orthopedic Braces & Supports
QMS built on EU MDR with zero FDA content. QMSR enforcement date had already passed. 31% compliant with 10 critical gaps.
Class III Cardiovascular Implants
Complex complaints backlog for high-risk devices, extended complaint closure timelines threatening vigilance compliance.
Medical-Grade Silicone Devices
Manual vigilance reporting, inconsistent complaints and adverse event reporting documentation
Surgical Instruments & Diagnostic Equipment
4 manufacturing sites with inconsistent QMS and a CAPA system not working effectively
Strategic insights for medical device manufacturers navigating FDA, ISO, and EU MDR compliance.
How AI-powered SaMD manufacturers navigate dual compliance under EU MDR and the EU AI Act. Covers Articles 9-15, MDR overlap mapping, and the practical 5-step compliance pathway before August 2027.
The 10 most common FDA Form 483 findings hitting medical device manufacturers in 2026. Updated for QMSR with actionable fixes from real inspection data.
Regulatory Excellence for Device Manufacturers. Elite Quality & Regulatory consultancy specializing in ISO 13485, FDA compliance, and medical device manufacturing excellence.
© 2026 VigilaMed Ltd. All rights reserved. Serving Class I, II, and III device manufacturers across UK, EU, and US markets.
Trusted by Industry Leaders
From cardiovascular device manufacturers to regulatory authorities, our expertise is recognized across the medical device industry.
Specialized in High-Risk Device Classes
Class I, Class II and Class III — From cardiovascular implants to active surgical instruments, we understand the stakes.