Medical device quality consulting

QMI Consulting

Quality is management applied with clear intent. We build quality systems that work in daily operations, not just in audits.

"Quality begins with the Intent which is fixed by Management." — W. Edwards Deming

Precision Quality Solutions

Studio photography of a metallic medical stent shown against a clean, light blue gradient background. This sterile, professional image highlights the intricate mesh design of the device.

Fractional Chief Quality Officer

Strategic QMS design and leadership for startups, providing executive-level oversight without the full-time investment. From design to release to market, your partner in Quality solutions

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Transformational Services

Modern eQMS option exploration and implementation. QMSR and other regulatory gap remediation to ensure your system operates within regulatory requirements daily

Studio photography of a diverse team reviewing documents in a high-tech manufacturing environment. The scene feels collaborative, clinical, and professional.

FDA, PMDA, ANVISA inspection Support

Comprehensive preparation and in-the-room support for inspections and audits, ensuring findings are managed with professional intent

Who We Work With

We partner with innovators at every stage, from agile startups building their first QMS to established design houses and manufacturers. Our systems ensure quality is management applied with clear intent, scaling alongside your operational growth.

Project-based

Strategic quality management solutions designed for specific regulatory milestones with a defined scope, ensuring clear deliverables

Retainer

Continuous senior quality leadership and ongoing compliance support to ensure operational consistency and maintaining the health of your quality system

Embedded on-site

Direct integration within your facility to operationalize compliance efforts, working alongside your team to resolve quality challenges day-to-day

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Principal Consultant

Robin Blankenbaker

Robin Blankenbaker brings over two decades of senior leadership in quality management and regulatory compliance. Her career spans medical devices, pharmaceuticals, and life sciences, where she has pioneered strategic solutions for both startups and established global manufacturers. As Principal Quality Management Consultant, Robin specializes in designing quality systems that transition seamlessly from regulatory requirements to daily operational excellence. Her approach ensures that compliance is not just a hurdle for audits and inspections, but a fundamental driver of management intent and product safety.

Book a 30-minute intake call

Tell us where your quality system stands and what you need. We will suggest a next step.

robinb@qmiconsulting.com

Phone

928-600-7365