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About us

QMS Evaluations LLC is an independent, third-party compliance partner dedicated to helping organizations achieve audit confidence, regulatory readiness, and sustainable quality performance.

We...

Specialize in the evaluation of Quality Management Systems, delivering objective, value-focused assessments that go beyond basic compliance. 

Identify system gaps, nonconformities, and opportunities for improvement, while also assessing whether resources, controls, and risk management processes are adequate to support ongoing compliance and continual improvement.

Support both medical and non-medical organizations operating in highly regulated environments.

Our...

Expertise includes ISO 9001:2015, ISO 13485:2016, and ISO 14971:2019, along with critical global regulatory frameworks such as EU MDR, EU IVDR, The UK Medical Devices Regulations 2002, and MDSAP. 

Services examine conformance, system effectiveness, and process execution, ensuring alignment with applicable international standards and regulatory requirements.

Focus is simple: clear insight, practical recommendations, and measurable value so our clients can strengthen their quality systems, reduce regulatory risk, and operate with confidence in global markets.

President & ceo

Mark Franco

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Satisfied clients

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Expert Internal Audit Reports

I am a Certified Quality Auditor with over 20 years of experience in the medical device industry, supporting organizations in achieving and maintaining global regulatory compliance through robust, effective quality management systems.  My expertise spans international standards and regulatory frameworks, including ISO 13485, EU MDR, MDSAP, and global market requirements.  I work closely with clients to lead audits and strengthen quality systems in ways that are both compliant and practical ensuring regulatory expectations are met without losing sight of business objectives.  I am known for a collaborative, hands on approach, partnering with leadership teams, quality professionals, and cross-functional stakeholders to build strong quality cultures and deliver sustainable improvements.  Whether preparing for audits, navigating regulatory change, or driving continuous improvement, my focus is on clarity, consistency, and long-term value.

My goal is simple: to help organizations achieve audit confidence, regulatory readiness, and operational excellence, enabling the delivery of safe, effective, and compliant medical devices to patients worldwide.