New FDA QMSR guideline! Your pathway to U.S. compliance starts here.
The FDA has introduced the Quality Management System Regulation (QMSR), replacing essential elements of 21 CFR Part 820 and aligning more closely with ISO 13485:2016. While many requirements may seem familiar, the new regulation introduces additional expectations that companies must address proactively.
Challenges introduced by the QMSR
The QMSR introduces new documentation, processes, and oversight requirements. At the same time, changes in the FDA´s inspection approach are expected. Companies will need to reassess their roles, processes, and documentation to ensure continued compliance and reduce inspection risks.
To support a smooth transition, the FDA recommends taking the following four essential steps:
1. Become familiar with the new regulatory requirement
2. Conduct a GAP analysis to identify compliance gaps and integrate new requirements
3. Implement robust and up-to-date documentation
4. Foster a strong compliance culture through targeted training and monitoring activities
Our QMSR Services
Our approach is precisely tailored to your needs and can include, but is not limited to:
- Regulatory Gap Assessment
WQS is conducting an in-depth analysis of your current quality management system against the QMSR, identifying gaps and areas for improvement. - Customized Compliance Strategy including Risk Assessment
Based on the gap analysis, we develop a tailored strategy to address identified gaps, ensuring your systems are fully compliant with the QMSR requirements. - Documentation Updates
We assist in reviewing and updating your documentation, including SOPs, Quality Manual, and records to meet the stringent documentation requirements of the QMSR and ISO 13485:2016. - Employee Training and Development
We provide targeted training programs to ensure your team is well-versed in the QMSR changes, their roles, and responsibilities within the updated system. - Preparation for FDA Inspections
With anticipated changes in the FDA’s inspection approach under the QMSR, we prepare you for inspections through mock audits and readiness assessments, ensuring your team is confident and prepared.
WQS has supported numerous companies in both Europe and the U.S. with ISO 13485:2016 and QMSR-aligned QMS implementation. Our consultants provide objective, pragmatic, and efficient guidance—ensuring a smooth transition without unnecessary complexity.
Ready for QMSR?
We will guide you through every step toward full compliance: https://us.wqs.de/contact/
Learn more: https://us.wqs.de/quality-management/
