VigilaMed: Regulatory Precision for High-Risk Medical Device Manufacturers

In the high-stakes world of Class II and Class III manufacturing, regulatory compliance is not a paperwork exercise—it is a commercial survival strategy.

Most consultancies trade in theory. They write procedures that look perfect on paper but fail the moment they hit the production floor. VigilaMed was built to close that gap. We deliver Manufacturing-First Compliance—evidence-driven systems designed to withstand the scrutiny of the FDA, Notified Bodies, and MDSAP auditors without choking your operational speed.

The Ethos: Evidence Before Opinion We reject "box-ticking." We build forensic, data-driven frameworks that protect market access. If a Quality System hinders production, it is a non-compliant system.

Core Capabilities We specialize in the heavy lifting required for US, EU, and UK markets:

Audit Defense: We do not just audit; we simulate the pressure of a real inspection. We train SMEs to defend data and manage the "backroom" strategy to keep auditors satisfied.

Forensic Remediation: From FDA Warning Letters to massive CAPA backlogs, we deploy teams to stop the bleeding. We quantify risk using our Cost of Inaction model, turning regulatory debt into stability.

QMS Architecture: Scalable systems for Design Control, Supplier Management, and PMS that integrate with engineering reality.

Leadership Led by Michelle Hilling (ISO 13485 Lead Auditor, FDA 21 CFR Part 820 Expert) and Kyle Holland (Head of Operations), we combine regulatory deep-knowledge with operational discipline.

Stop the Bleeding. Secure Your Market Access. The regulatory landscape of 2026 is unforgiving. You do not need a consultant who knows the rules; you need a partner who knows how to win within them.

Web: www.vigilamed.com Focus: FDA | ISO 13485 | MDSAP | EU MDR

VigilaMed

Org chart

Teams

Offices