Regulatory Certainty for High-Risk Medical Devices.
Built for Class I, Class II and Class III manufacturers who cannot afford regulatory surprises.
Our Story
VigilaMed was founded on a simple premise: Regulatory compliance should accelerate manufacturing, not stifle it.
Born from the production floors of major device manufacturers, we saw the disconnect between theoretical compliance and operational reality. We built VigilaMed to bridge that gap, providing expert regulatory guidance that is practical, defensible, and deeply rooted in the realities of making medical devices.
Most consultancies are built on theory. VigilaMed was built inside medical device manufacturing environments.
Documentation Theory
QMS systems that look compliant but fail under audit.
Design controls written without manufacturing reality.
CAPA systems that never truly close.
Internal teams stretched between output targets and regulatory expectations.
Manufacturing Reality
Practical, evidence-driven systems embedded in production.
Design controls that support efficient design transfer.
CAPA systems that withstand auditor scrutiny.
Quality systems designed to pass audits — and keep passing them.
VigilaMed was created to close that gap — delivering practical, evidence-driven quality & regulatory systems that work in real manufacturing conditions.
Leadership
Michelle Hilling
Managing Director
VigilaMed is led by Michelle Hilling, a Quality & Regulatory professional with over 10+ years of experience embedded in medical device manufacturing environments.
Michelle has supported manufacturers across Class I, II, and III devices, guiding organizations through ISO 13485 certification, FDA submissions, and post-market compliance.
Her experience includes work with industry leaders like Terumo and GC Aesthetics, shaping her disciplined, practical approach to quality systems that serve both regulatory requirements and commercial goals.
Kyle Holland
Head of Operations & Systems
Kyle oversees VigilaMed's operational infrastructure, digital systems, and internal processes that support the firm's delivery and long-term scalability.
He is responsible for building and maintaining the systems that enable efficient client engagement, structured service delivery, and consistent operational standards ensuring VigilaMed operates as a stable, dependable partner for high-risk medical device manufacturers.
By managing the firm's internal workflows, technology platforms, and business systems, Kyle allows regulatory leadership to remain fully focused on client compliance, audit readiness, and manufacturing outcomes.
Our Approach: Manufacturing-First Compliance
We do not treat compliance as paperwork.
We design and implement Quality and Regulatory systems that integrate with how devices are actually designed, built, validated, and monitored post-market.
Adverse Event Reporting
Rapid, evidence-based vigilance systems that ensure 100% reporting compliance without exposing the organization to unnecessary regulatory risk
CAPA Systems
CAPA systems that withstand auditor scrutiny, ensuring issues are properly investigated, addressed, and verified for effectiveness.
Complaint Handling Systems
Complaint workflows designed to withstand deep regulatory scrutiny, ensuring robust investigation, accurate risk coding, and definitive closure for every event.
Audit Preparation
Audit preparation that eliminates last-minute remediation, with systems designed to pass inspections — and keep passing them.
Our work is measured by outcomes — not documents produced.
Ready to Work With VigilaMed?
If you're preparing for an audit, launching a high-risk device, or strengthening your manufacturing compliance framework, we'd welcome a conversation.