QMS Requirements: What’s Needed for GLP Studies and IDE Trials vs. Commercial Distribution

December 4, 2025

Medical device innovators often ask: “Do we need a fully implemented Quality Management System (QMS) to begin a GLP animal study or an IDE clinical trial?” The short answer is: not fully, but key quality processes must still be in place. Understanding when and how regulatory QMS requirements apply can save time, reduce risk, and streamline your path to commercialization.

At Folio Consulting Group, we guide clients through the evolving regulatory landscape, including strategic planning for quality systems during early-stage development. In this post, we break down what’s required under FDA regulations and ISO 13485:2016, and how you can prepare your QMS for each phase of your product lifecycle.

Regulatory Context: What Applies and When

The FDA’s Quality System Regulation (QSR), outlined in 21 CFR Part 820, governs quality requirements for finished devices intended for commercial distribution in the U.S. This means full QMS implementation is only required when you’re preparing for market entry, not during early research or clinical investigation phases.

However, upcoming changes are on the horizon:

• The Quality Management System Regulation (QMSR), a revised version of Part 820, will go into full effect on February 2, 2026, aligning FDA requirements with ISO 13485:2016 by reference.

Until then, device manufacturers must comply with current Part 820. But it’s important to note that devices under investigation (such as those in an IDE study) are exempt from most of 21 CFR Part 820, except for design controls under 820.30.

Strategic Takeaway: What You Do Need During Development

If you’re conducting a GLP animal study or an IDE clinical trial, you’re not yet distributing a finished device commercially. But that doesn’t mean quality requirements don’t apply.

At this stage, your QMS doesn’t need to be fully implemented, but you should establish certain quality controls that ensure traceability and good documentation practices.

Your QMS at this phase should focus on elements that provide:

• Design traceability

• Controlled documentation

• Manufacturing reliability

• Supplier oversight

• Risk mitigation

Pre-Commercial QMS Elements to Prioritize

From an ISO 13485:2016 perspective, these are the most critical quality system elements to implement before starting your GLP or IDE activities:

• Document and Records Control (Sections 4.2.4 & 4.2.5) - Ensure procedures and records are properly maintained, accessible, and revision-controlled.

• Work Environment and Contamination Control (Section 6.4) - Maintain appropriate cleanliness and control measures, especially in production or test environments.

• Design and Development Controls (Section 7.3) - Implement controls to document and validate your device’s design evolution, which supports compliance with 21 CFR 820.30.

• Purchasing Controls (Section 7.4) - Establish oversight for critical materials and components, including supplier qualifications and evaluations.

• Production and Service Provision (Section 7.5) - Implement controls around production, cleanliness, process validation (as needed), and traceability, particularly if your prototype is sterilized or used in human/animal testing.

Plan for Scale: Positioning for Commercial Compliance

When you move into commercialization, full QMS compliance is required. That includes meeting the full scope of 21 CFR 820 or ISO 13485:2016 once QMSR is enforced in February 2026.

To ease that transition, consider preparing a quality plan during development that defines which QMS elements you will implement and when, as well as which areas are deferred, with rationale and a timeline or milestone for completion. This approach not only clarifies your current compliance status but also demonstrates strategic foresight to both regulators and potential investors.

Final Thought: Build Quality Early and Purposefully

Regulatory requirements evolve, and so should your quality system. A phased, risk-based approach to QMS implementation lets you meet your current regulatory obligations while positioning your organization for successful market entry.