This article is the first in a five-part series on how agile methods, applied with hardware-ready tactics, deliver better outcomes for medical device companies. It presents a systematic approach to the relationship between 21 CFR 820 and ISO 13485 compliance that builds speed and confidence. 

Executives face three consistent pressures: get products to market faster, remain fully compliant, and improve ROI. Traditional waterfall development slows innovation and increases risk; pure software agile doesn’t fit the regulated realities of devices.

The Modified Agile for Hardware Development (MAHD) Framework resolves this tension. By leveraging iterative learning cycles, cross-discipline alignment, and living traceability, MAHD helps organizations reduce risk, accelerate innovation, and keep compliance audit-ready.

In this first article, the focus is on how MAHD principles can help companies accelerate the transition to the FDA’s new Quality Management System Regulation (QMSR)—a change that could otherwise bog down teams for years.

What Changed—and Why It Matters

The FDA’s new Quality Management System Regulation (QMSR) comes into effect on Feb. 2, 2026, harmonizing 21 CFR 820 with ISO 13485:2016. Its intent:

• Global alignment: Reduce redundant compliance burdens for companies operating worldwide
• Clarity of language: Adopting ISO 9000 Clause 3 definitions for consistency
• Modernization: Embedding risk management throughout the product lifecycle

However, alignment isn’t trivial. Many organizations have decades of standard operating procedures, templates, and training built around the old QSR numbering and terminology. FDA declined to issue a clause-by-clause mapping, leaving the burden of translation with manufacturers.

The Transition Challenge

QMSR alignment can feel daunting because it touches every function—quality, regulatory, R&D, operations, and supply chain. Without a structured approach, the transition risks becoming a massive, one-time compliance project that drains resources and delays innovation.

How Agile Can Accelerate Alignment

The QMSR transition can be approached in two complementary ways using agile methods such as those provided within the MAHD Framework:

Path 1: Treat QMSR Transition as an Agile Project

For companies wanting to manage the transition centrally across functions or the whole organization, agile methods can provide an iterative, learning-based approach to lower risk and boost confidence.

1. Leverage the On-Ramp & Focus Matrix

• Begin with a MAHD Vision Brief describing the regulatory transition goals.
• Use the Focus Matrix to map clauses to processes to records, and identify “big rocks” that need early attention. 

2. Run Iterative Resolution Cycles

• Instead of tackling clauses in isolation, MAHD emphasizes a systematic approach that addresses the most critical clauses first, always considering how changes ripple across the broader system.
• Each cycle reinforces alignment across processes, records, and responsibilities—ensuring overall compliance and efficiency rather than feature-by-feature fixes.
• Progress is measured by increased compliance clarity and reduced risk exposure, not just the number of clauses reviewed.

3. Build Transparency Across Groups

• Establish cross-functional review points at the end of each iteration.
• Provide executives with visible progress dashboards showing clauses aligned, owners assigned, and records completed. 

Path 2: Integrate QMSR Alignment into Product Development as a Swim Lane

For organizations wanting to take a more integrated approach to align the two processes with devices already in development, an agile QMSR transition can run in parallel with product development work.

1. Make Compliance a Dedicated Swim Lane

• In the MAHD model, work is divided into swim lanes for engineering, clinical, manufacturing, etc.
• Adding a QMSR swim lane ensures focus, accountability, and traceable progress, while staying aligned with broader project goals.

2. Keep QMSR Items in the Aligned Backlog

• The backlog connects tasks to their swim lane while staying aligned to overall IPAC iteration goals. 
• Compliance work—such as design inputs, risk files, and design history file updates—is fully integrated, not siloed.

3. Scale Change Control with Iterations

• Early iterations emphasize identifying and addressing risks with lightweight approvals.
• Later iterations apply full rigor, producing auditor-ready change records that meet FDA and ISO expectations. 

Why This Matters

Framing the QMSR transition with an agile approach provides tangible results.

• Faster transition: Iterative resolution cycles create rapid compliance clarity.
• Reduced compliance risk: Living traceability keeps evidence current and audit-ready.
• Collaborative alignment: Embedding compliance as a swim lane means new product development with compliance and alignment built in.
• Clear oversight: Executives get transparent dashboards linking clause to process to tracking, with visible ownership and status.

Conclusion

FDA’s QMSR shift is more than a compliance update—it’s an opportunity to rethink how compliance work gets done. By treating the transition itself as an agile project, or embedding it with agile methods within ongoing development, companies can accelerate alignment, maintain innovation velocity, and strengthen compliance confidence. With agile methods designed for hardware, executives don’t have to choose between speed and safety—they get both.

Dorian Simpson is an innovation, product management, and agile consultant, trainer, and speaker. He is the author of “The Savvy Corporate Innovator” and founding partner of the Modified Agile for Hardware Development (MAHD) Framework. He helps startups to Fortune 500 technology leaders build skills to improve their ability to identify, evaluate, plan, and develop innovative products. The MAHD Framework is a purpose-built agile approach for physical product innovation. MAHD combines agile principles with hardware-ready methods: On-Ramps to set strategic intent, IPAC Iterations to integrate and learn quickly, Aligned Backlogs to connect work across disciplines, and hardware-aligned roles that empower technical leaders. Organizations adopting MAHD report faster time-to-market, improved compliance confidence, and higher ROI—without sacrificing safety or quality. Learn more at www.MAHDFramework.com.