Medical device quality is entering one of the most consequential transition periods in decades. With the FDA’s Quality Management System Regulation (QMSR) now in effect, expanding digital access to quality records, evolving ISO standards, and increased scrutiny of digital health technologies, 2026 will test whether quality systems are truly effective or merely compliant on paper.
Based on Rook Quality Systems’ direct experience supporting FDA inspections, regulatory submissions, and remediation efforts across the industry, the following five predictions highlight where regulatory expectations are tightening and where quality teams should focus now to reduce risk later.
FDA Inspection Findings Will Increase for Management Review and Internal Audits Under QMSR
In 2026, Rook predicts that FDA inspection findings related to Management Review and Internal Audits will increase as these processes become primary indicators of quality system effectiveness under the QMSR.
What's Driving This Prediction?
QMSR aligns FDA quality requirements more closely with ISO 13485, changing how investigators assess Management Review and Internal Audit. Key drivers include:
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Expanded FDA access to the actual content of Management Review meetings and Internal Audit reports, including agendas, minutes, findings, trends, and follow-up actions
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A shift from verifying completion of these activities to evaluating whether they meaningfully demonstrate oversight, risk awareness, and continuous improvement.
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Increased visibility into recurring issues, weak follow-through, and unresolved actions that were previously contained within internal discussions.
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Greater scrutiny of Internal Audit programs, including auditor competence, documented training, and defined qualification requirements, not just independence.
How Teams Can Prepare:
Manufacturers should treat Management Review and Internal Audit as core operating processes, not compliance checkboxes. Management Reviews should be risk-based, data-driven, and clearly tied to quality and business decisions. Internal Audit programs should define and document auditor qualification criteria, such as recognized audit training, defined quality or regulatory experience, or a combination of both, and demonstrate clear linkage between audit findings, CAPAs, and management oversight.
Rook helps organizations strengthen Management Review and Internal Audit processes so they stand up to deeper FDA scrutiny and demonstrate true quality system effectiveness.
FDA Will Narrow the Definition of “General Wellness” for Wearables and Continuous Monitoring Devices
The Rook Team predicts that in 2026 FDA will issue an updated guidance, enforcement clarifications, or continued warning letters that further narrow what qualifies as a “general wellness” device-particularly for wearable fitness trackers and continuous monitoring technologies.
What's Driving This Prediction?
The rapid growth of wearable devices capable of tracking physiological parameters has blurred the line between wellness products and regulated medical devices. FDA’s General Wellness guidance was never intended to cover devices that:
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Monitor or trend vital signs
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Influence clinical decision-making
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Are marketed to higher-risk or disease-specific populations
Recent enforcement actions, including warning letters issued to wearable manufacturers, signal that FDA is increasingly unwilling to accept wellness positioning when device functionality or claims suggest medical intent.
How Teams Can Prepare:
Manufacturers relying on general wellness exemptions face heightened regulatory risk if claims, labeling, or real-world use exceed FDA’s tolerance. Quality systems, design controls, and post-market surveillance expectations may apply sooner than anticipated.
Rook helps teams reassess intended use, claims strategy, and regulatory classification early-reducing the likelihood of enforcement action or costly rework after product launch.
ISO 10993-1:2026 Will Reshape Biocompatibility Risk Assessments Ahead of Clear FDA Implementation Guidance
Our team anticipates that the transition from ISO 10993-1:2018 to ISO 10993-1:2026 will significantly alter how biocompatibility risk is assessed, even as FDA guidance on implementation lags behind the standard’s publication.
What's Driving This Prediction?
ISO 10993-1:2026 introduces substantial updates, including:
- Revised approaches to estimating biological risk
- Expanded requirements for foreseeable misuse
- Greater emphasis on lifecycle and end-of-life considerations
These changes modernize a standard that has guided biocompatibility evaluations for nearly a decade-but they also introduce uncertainty as manufacturers await FDA alignment and formal recognition.
How Teams Can Prepare:
Waiting for perfect regulatory clarity increases submission and inspection risk. FDA has historically expected manufacturers to justify scientific rationale during periods of transition, even when guidance is still evolving.
Rook supports proactive gap assessments, risk-based justifications, and defensible biocompatibility strategies that align with both current FDA expectations and emerging ISO requirements.
Continuous Digital Access Will End “Inspection Readiness” as a Temporary State
Rook’s team of consultants anticipates that in 2026, inspection readiness will no longer be a periodic activity. As the FDA continues to expand its digital access to quality records, inspection readiness will become a continuous, ongoing requirement.
What's Driving This Prediction?
Digital QMS platforms, remote inspections, and electronic record access mean FDA investigators can quickly identify inconsistencies across procedures, records, and execution.
Organizations with:
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Fragmented documentation systems
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Inconsistent recordkeeping practices
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Manual, institutionally dependent processes
will find it harder to explain gaps that were once less visible.
How Teams Can Prepare:
Quality systems must operate as integrated, living systems-not static collections of SOPs. Alignment, traceability, and execution consistency will be as critical as written compliance.
Rook helps organizations assess inspection readiness holistically, ensuring quality systems are defensible every day-not just during audits.
FDA Will Expect Quality Systems to Scale With Organizational and Product Complexity
In 2026, Rook's consultants predict that the FDA will increasingly evaluate whether a manufacturer’s quality system scales appropriately with its product portfolio, risk profile, and organizational growth.
What's Driving This Prediction?
As companies expand globally, add products, or move into higher-risk indications, FDA expects quality governance, risk management, and oversight to evolve accordingly. Startups and mid-size manufacturers transitioning out of early-stage operating models are particularly vulnerable.
How Teams Can Prepare:
Quality systems designed for early development often fail under commercial and global regulatory demands. FDA scrutiny will focus not just on compliance, but on maturity and scalability.
Rook partners with growing organizations to design scalable quality systems that support long-term growth, global alignment, and regulatory confidence.
Looking Ahead In 2026
The defining theme of medical device quality in 2026 is visibility. Regulators will see more, expect more, and tolerate less ambiguity. Organizations that invest now in disciplined, risk-based, and scalable quality systems will be best positioned to navigate inspections, submissions, and market expansion without disruption.
Rook Quality Systems helps medical device companies anticipate regulatory shifts, translate expectations into action, and build quality systems that stand up to scrutiny today, and in the years ahead.