7 Steps to Comply with FDA's QMSR

About the QMSR

The FDA has revised the current QSR and released the final rule for Quality Management System Regulation (QMSR). The design goal of QMSR is to promote consistency in medical device regulation, ensure that safe, effective and high-quality products are promptly brought to the market, and reduce the compliance burden on enterprises by aligning with the international standard ISO 13485:2016. The QMSR regulation will officially come into effect on February 2, 2026.

How to Comply with FDA's QMSR

Medical device enterprises affected by QMSR regulations can systematically carry out compliance preparations through the following 7 key steps.

1. Understand the QMSR Requirements in Detail

The enterprise should read the final rules of QMSR and the full text of ISO 13485:2016 comprehensively, with a focus on understanding the new requirements and their differences from the current regulations.

2. Conduct a Gap Analysis

The enterprise should compare the existing quality management system with QMSR and ISO 13485:2016 item by item, identifying non-compliance issues and areas for improvement.

• Establish a cross-functional team, with each member responsible for interpreting clauses and reviewing the processes.
• Organize the existing QMS documents.
• Use a structured approach to compare the current QMS with the new requirements.
• Mark out the FDA-specific requirements.
• Prioritize the key gaps based on the risks to product quality, patient safety, and regulatory compliance.
• Prepare a detailed gap analysis report and action plan, and submit it for review by management.

3. Develop Implementation Plans

Based on the gap analysis results, develop an implementation plan, clearly defining the schedule, responsible persons, resource allocation and training needs.

• Classify the gaps by risk level and prioritize the resolution of high-risk projects.
• Divide the rectifying tasks into specific projects and work tasks, and formulate a detailed action list.
• Identify the responsible person for each task and set achievable time nodes.
• Establish key milestone checkpoints to monitor progress.
• Develop targeted training plans for the different roles.
• Evaluate the required resources and implement their allocation.
• Regularly report on project progress and promptly adjust to address the challenges.

4. Train Team Members

The enterprise should provide training to employees on the relevant contents of QMSR and ISO 13485:2016 to ensure that key positions understand and fulfill their respective responsibilities.

• Analyze training needs to identify knowledge gaps.
• Group by responsibilities and develop layered training content.
• Enhance understanding through examples, cases and practical training.
• Assign experienced internal or external lecturers to teach.
• Establish a training record file for review.

5. Update the Quality Management System Documents

Based on the gap analysis and training feedback, revise or add the necessary QMS documents and processes.

• Start with updating the quality policy and manual, and then expand to various SOPs.
• Create new processes, such as risk management, design control, and supplier management.
• All documents need to be uniformly managed through a document control system.
• The risk management system needs to be updated in accordance with ISO 14971 and undergo training.
• Update quality objectives and quality plans, revise quality control methods.
• Verify and validate new or significantly changed processes.

6. Plan and Implement Internal Audits

Ensure that the implemented QMS improvement measures are effective through internal audits, and improve them further.

• Define the scope and frequency of the audits, covering all key change points.
• Assign qualified auditors to ensure independence and professionalism.
• Develop an audit checklist based on QMSR and ISO 13485:2016.
• The audit methods should include document review, interviews, on-site observation, etc.
• Write an audit report, listing non-conformities and corrective suggestions.
• Develop and track corrective measures, conduct follow-up audits.

7. Prepare for FDA On-site Inspections

Prepare all the documents and records that meet the requirements of QMSR and ISO 13485:2016 in advance, ensuring the response capability during the FDA inspection.

• Be familiar with the inspection guidelines and key points of the FDA.
• Sort out all QMS documents to make the structure clear and easy to search.
• Keep training records, internal audit reports, CAPA files, management reviews and other materials updated.
• Organize mock inspections or invite external consultants to assist in the drills.
• Establish a dedicated team to handle inspections, with a clear division of responsibilities.
• Training employees on how to respond to reviews, including how to answer and present materials.
• Ensure that supplier management system documents are complete and auditable.

The implementation of QMSR marks a significant turning point in the global medical device compliance strategy. If medical device enterprises can seize this opportunity and actively implement the above seven-step strategies, they will not only meet compliance requirements, but also gain trust and competitive advantages on the global market.

As a reliable compliance partner, closely follows global regulatory trends, Proregulations deeply analyzes the differences and connections between the FDA and ISO 13485:2016, and provides enterprises with full-process compliance support ranging from gap analysis to system reconfiguration.

Here are some of the relevant compliance services we provide:

• Regulatory interpretation and consultation
• Regulatory training
• Gap analysis
• Compliance assessment
• Technical document review and optimization
• Risk management
• FDA local agent

Proregulations is dedicated to assisting medical device enterprises in effectively addressing international regulatory challenges. Whether you are in the strategic planning stage, the rectify implementation phase, or the inspection response period, we can provide you with professional, efficient, and practical solutions. If you are interested in our services, please contact us.

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