Quality and Regulatory Solutions
Guardian QRS helps medtech companies build compliant quality systems, clear regulatory submissions, and reach the market faster, without losing sight of what matters most: getting safe devices to patients.
What we do
From first quality system to global market access, Guardian QRS delivers the regulatory and quality work early-stage medtech teams need, with the judgment of an in-house director.
Build, remediate, and maintain a quality management system that is audit-ready and right-sized for your stage.
Readiness assessments and transition support for the FDA Quality Management System Regulation, effective February 2026.
Technical documentation, conformity strategy, and named Article 15 Person Responsible for Regulatory Compliance accountability.
Single-audit readiness across the United States, Canada, Australia, Brazil, and Japan, mapped to one program.
Risk management files and processes that connect to design, production, and post-market, and hold up under scrutiny.
Submission strategy, gap analysis, and authoring, from planning through clearance or certification.
Navigate electrical medical device safety and essential performance testing with your test lab and design team.
Governance for AI-enabled devices and internal AI tools, aligned to ISO/IEC 42001 and evolving FDA expectations.
A fixed-scope engagement that benchmarks your quality system against the new FDA QMSR and ISO 13485:2016, with a prioritized, practical remediation roadmap you can act on immediately.
Start an assessmentEmbedded, part-time regulatory and quality leadership with a real title and real authority. Senior direction for teams that are not ready to hire a full-time VP or Director.
Discuss a fractional roleYour QRS Solutions Architect
Guardian QRS is the regulatory and quality partner for medical device companies that need senior expertise without a senior-level headcount. Founded by Christopher A. Henderson, the practice brings deep, hands-on experience across FDA QMSR, ISO 13485, EU MDR and PRRC accountability, and MDSAP to teams building real products under real deadlines. The work is practical and outcomes-first: quality systems that fit how you actually operate, submissions built to clear, and defensible records that stand up to auditors and notified bodies. Whether you are standing up a QMS for the first time, preparing for a submission, or need a named regulatory leader to carry accountability, Guardian QRS helps you move to market with confidence and keep patients safe.
Get in touch
Tell us where you are and where you need to be. We will follow up to schedule a short, no-pressure consultation.