The FDA’s new Quality Management System Regulation (QMSR)—the next evolution beyond 21 CFR 820—is fully effective on February 2, 2026. Any company that has not reviewed or updated their systems to meet the new integration of ISO 13485 requirements is at risk.
With FDA fully adopting the ISO 13485 standard, companies worldwide will face a last-minute scramble to upgrade their systems and processes. Compliance Architects, with deep expertise in medical device quality regulation and systems development, stands ready to drive final implementation activities onsite at your facilities.
A Hard Deadline: With the QMSR deadline approaching, every day counts. In some cases, immediate action may be necessary to prevent major rework and regulatory risk later.
Comprehensive Compliance; Quality Risk Focused: Our seasoned specialists are well-versed in legacy 21 CFR 820, the new QMSR, and ISO 13485. We will ensure that your quality management system meets the new requirements and expectations that come with the ISO 13485 standard.
Risk Mitigation: Avoid costly delays, regulator concerns, and potential market entry issues by aligning your operations with the new requirements today.
Identify the gaps between your current quality management system and the new QMSR requirements. Using a proprietary computer-based platform, we perform a rigorous gap analysis, highlighting critical areas for immediate attention, and providing an easy-to-understand report on areas of prioritized focus.
Transitioning from 21 CFR 820 to ISO 13485 under QMSR isn’t a simple document change—it’s a transformation of your entire quality system, including quality culture. We guide you through updating quality manuals, work instructions, change controls and more to ensure you are ready for February 2026.
Ensure your teams are fully equipped with the skills and knowledge required to maintain a compliant system. Our customized training programs are designed to instill a proactive compliance mindset.
Implement robust risk management and corrective action processes that align with both FDA and international standards, safeguarding your products and reputation. There will always be gaps to address – we help you understand risk and focus on what’s important to maximize risk reduction while considering operational capability.
Our consultants help reinforce executive leadership’s role to achieve compliance to the new regulation by ensuring quality monitoring and continuous improvement, keeping your compliance efforts on track over the long term.
With decades of experience in medical device regulation, we’ve seen regulatory changes — and we know how to navigate them. Our consulting team has built their reputation on not only understanding the technical details of quality management systems but also on providing hands-on, strategic support tailored to your business operations.
Customized Consulting: Every company is unique. We tailor our approach to your specific product(s) risk profile, business model, operational needs, regulatory challenges, company size, and market dynamics.
John Daley
Executive Consultant, Medical Devices & Diagnostics
Pedro Martinez
Executive Consultant, Medical Devices & Diagnostics
John C. (Jack) Garvey
Founder & CEO
John is a nationally recognized voice in the medical device regulatory space and one of the industry’s foremost experts on QMSR. With deep expertise in both legacy 21 CFR 820 and ISO 13485, John helps clients understand not just what is changing but why it matters to their business.
He has written extensively on QMSR transition strategy, and his client work focuses on ensuring that CAPA, risk management, and executive oversight aren’t treated as check-the-box activities but as integrated, risk-driven processes that regulators expect.
“The QMSR is more than a name change. It’s a shift in regulatory philosophy. The FDA is no longer just asking if your documents are in order. They want to know if your system actually works.”
“Many companies risk mapping their old systems to the new language. But QMSR is about performance, not paperwork. That’s the difference between passing an inspection and failing one.”
Pedro is a seasoned quality and regulatory leader with over 25 years of experience across drugs, biologics, and combination products. He’s known for designing and implementing inspection-ready systems that meet FDA and global requirements—without losing sight of business realities.
At Compliance Architects®, Pedro helps clients align their quality strategies with operational goals, guiding everything from remediation and system design to regulatory risk management. His practical, systems-focused approach ensures compliance is built to last.
Jack brings over 30 years of deep regulatory and quality experience across medical devices, pharmaceuticals, and combination products. As the founder of Compliance Architects®, he has led countless teams through complex compliance challenges with a unique blend of legal, operational, and quality expertise.
Jack has worked extensively with medical device companies to design and remediate Quality Management Systems, always with an eye toward sustainable compliance and business performance. His thought leadership—such as comparing ineffective quality programs to the “Winchester House” of Quality—demonstrates his clear, strategic thinking in a highly regulated space.
With Jack’s oversight, clients can count on a grounded, forward-thinking approach that keeps quality aligned with business goals.
With decades of experience and a practical, systems-first mindset, John and Pedro are trusted by industry leaders to drive regulatory success. When you partner with Compliance Architects®, you’re not just getting advice. You’re getting the confidence that your compliance strategy is in the right hands.
Don’t let a rush to compliance result in oversights that could impact your business, your products, and your patients.
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