3 Simple Steps to Transition to QMSR

In January, the U.S. Food and Drug Administration (FDA) published the final rule harmonizing the Quality System Regulation (21 CFR 820) with ISO 13485:2016. This update incorporates the requirements of ISO 13845 by reference and includes definitions from ISO 9000 Clause 3. The new FDA regulation, called the Quality Management System Regulation (FDA QMSR), will usher in an era of harmonization for medical device quality standards, simplifying medical device QMS compliance.

FDA QMSR Updates

While most of the FDA QMSR will incorporate ISO 13485 and ISO 9000 Clause 3 by reference, the FDA QMSR clarifies certain FDA expectations and concepts related to:

• Terms and Definitions:

  While adopting the definitions of ISO 9000 Clause 3, some terms are unique to the FDA QMSR and supersede ISO terminology. The FDA QMSR also introduces definitions not included in ISO but necessary for medical device QMS compliance with the rest of the CFR.

• Identification and Traceability:

  The FDA QMSR requires unique device identifiers (UDIs) to be applied to all medical devices in compliance with 21 CFR 830. This requirement is unique to FDA QMSR and expands on the identification and traceability clauses of ISO 13485.

• Complaint and Servicing Records:

  While ISO 13485 requires complaint management, the FDA QMSR requirements include adherence to 21 CFR 803, Medical Device Reporting. This section gives specific requirements for reporting and documenting adverse events and customer complaints. The FDA QMSR allows previously investigated issues to reference existing complaint and servicing records with a justification instead of a new investigation.

• Advisory Notices:

  This section presents additional requirements to those defined in 13845 clause 7.2.3. The FDA QMSR aligns with 21 CFR 806, Medical Devices; Reports of Corrections and Removals, outlining what manufacturers must do in the event of a device correction or recall.

• Design and Development:

  QMSR harmonization changes here mainly relate to document terminology. The terms quality system record, device master record, and design history file and record are replaced with the term medical device file (MDF) in ISO 13845 clause 7.5.1.

• Control of Records:

  In addition to ISO requirements, the FDA QMSR now allows the FDA to inspect medical device internal audit records during an FDA inspection.

• Additional Record Control:

  UDIs must be recorded on all medical device QMS records, with confidentiality maintained.

• Device Labeling and Packaging Control:

  The FDA QMSR provides clarity to the requirements in ISO 13485 Clause 7.5.1. Detailed labeling and packaging processes must include UDI or UPC, and inspection of labels and packaging must ensure match to the MDF.
  

Many may wonder how QMSR harmonization will impact their medical device QMS. No matter the complexity of the quality management system or medical device, here are three simple steps device manufacturers should take to simplify the transition to the FDA QMSR.

1. Conduct a Gap Analysis to Determine a Risk-Based Action Plan

The first step to any regulatory update is to assess the current status. A thorough medical device gap analysis of the FDA QMSR against the existing quality management system should be conducted. If traceability already exists between the Quality System Regulation (QSR) or ISO 13845 and the medical device QMS, the organization is ahead of the game.

Depending on the size of the organization, forming a FDA QMSR transition team might be beneficial. Assign different sections of the medical device gap analysis to FDA QMSR transition team members based on their roles to streamline the process. For instance, the engineering department might assess design controls, while quality assurance reviews the medical device QMS.

A medical device gap analysis essentially serves as a checklist of FDA QMSR requirements and the current compliance status. When the medical device quality management system meets a requirement, the medical device gap analysis should detail how the requirement is met. For example, if Section 2 of the Quality Manual met the requirements outlined in ISO 13845 Section 4.2.2, the medical device gap analysis documents that compliance. (Figure 1 & Figure 2)

Figure 1: QMSR gap analysis outlining regulatory requirements

Figure 2: QMSR gap analysis records compliance

However, if a gap exists, the medical device gap analysis should clearly list the gap. (Figure 3) List all the FDA QMSR requirements. Then, check if the management system meets each one or if there are any gaps. This will provide a comprehensive map of what needs to be done to be in compliance with the FDA QMSR by February 2026.

Figure 3: QMSR gap analysis records gaps

2. Update QMS Documentation According to Risk

After the medical device gap analysis is complete, the FDA QMSR transition team should assess the risk presented by each identified gap. Each gap should be assessed for its potential impact to quality, business, and regulatory requirements. The management team determines what needs to be done, assigns who will do it, and sets deadlines.

A more detailed risk assessment can be conducted by adding a scoring system for consequences and likelihood. Multiplying these scores generates a risk value, which helps prioritize higher-risk gaps in the medical devices quality management system. Regular meetings with the team will ensure actions are tracked and completed on time. (Figure 4)

Figure 4: Tracking gap closure

3. After Updates, Conduct Internal Audit of Processes to Ensure There Are No Gaps

After the FDA QMSR transition team has completed the medical device gap analysis and closed the gaps, conducting a medical device internal audit is a great way to ensure all the gaps have been adequately addressed. The medical device internal audit should be conducted by someone completely independent of the mitigation activities. In smaller organizations, this may require contracting an outside auditor. If the audit uncovers any additional gaps, repeat the update process to ensure compliance.

Conclusion

QMSR harmonization marks a significant milestone in medical devices quality management system. Understanding and embracing the transition will allow regulatory compliance and new opportunities for growth in the global medical device market.

Join us on October 13 at Masters Summit 2024 in Salt Lake City for a deeper discussion of QMSR harmonization and steps you can take to facilitate compliance with the updated regulation. The Cannon Quality Group team will host a session devoted to discussing the harmonized regulation, and you can get answers to any specific questions you may have by emailing them in advance to [email protected] or drop your questions here for an opportunity to win a prize at Masters Summit.