The majority of MedTech firms we advice have commercialization in the US market as a key element of their business and GTM strategy. This puts them directly under the jurisdiction of the US Food & Drug Administration, one of the most prominent and influential regulatory agencies in the medical device industry whose activities we monitor closely.
For these reasons we are informing MedTech firms presently engaged with the Food & Drug Administration, or planning to do so in the future, of an important Quality Management System Regulation (QMSR) rules amendment that impacts their medical device development and manufacturing practices in the US.
FDA Quality Management System Regulation (QMSR) to replace Quality System Regulation (QSR)
The FDA’s Quality Management System requirements are changing. The existing QSR regulation will be augmented to include the new QMSR requirements to more closely align with ISO 13485 standards with notable additions. The deadline is approaching fast and becomes effective on February 2, 2026.
Whether your company is already on the market in the US or working on it, if you are:
- Currently developing a QMS with Canadian, US or European scope.
- Already ISO 13485 or MDSAP-certified.
- Already FDA QSR-compliant.
Your firm will need to do some work to integrate the new QMSR requirements into your development processes.
Do you have questions on how the expanded Food & Drug Administration Quality Management System Requirements (QMSR) for Medical Devices impacts your firm?
Contact BML Health today and find out.
We encourage MedTech firms to move fast to address these updates if they haven’t already. A failure to follow the new Quality Management System Regulation (QMSR) requirements may lead to delays and setbacks in their medical device development process in the US.
If your company needs support BML Health is assisting firms adapt to this change with our close partners in QMS support. We can provide gap assessments of full hands-on compliance support as required.
Some of the changes that the new QMSR process will require from firms include:
- Formal Audits:
Internal and supplier audits must now be available for FDA review, just like in ISO 13485. - Quality Manual Updates:
The quality manual will need to reflect new terminology and requirements aligned with ISO 13485. - Updates to Risk Management:
Risk management practices must be more explicitly integrated and documented throughout the quality system. - Supplier Controls:
Supplier evaluation and controls will need to meet the detailed expectations set in ISO 13485. - Record Controls:
All records, including audit and risk management files, must be maintained and accessible using the ISO 13485 structure.
What should MedTech companies do next
If your MedTech company is a BML Health client we have more than likely been in close contact and are actively conducting meetings to assess your needs and plan for the integration of the new QMSR requirements.
If your firm is not a BML Health client and you have questions or concerns on how the new QMSR requirements will impact your company we invite you to contact us to book a meeting and plan your compliance to avoid any issues in the US market in the new year.
BML Health will continue to provide updates on the Food & Drug Administration’s expanded Quality Management System Requirements (QMSR) for Medical Devices as necessary and again we invite you to keep in touch and contact us if you have questions.
About BML Health
We support innovative Medtech companies that are shaping the future of healthcare. BML Health understands the impact of emerging technology in MedTech and Digital Health. Get in touch with us to learn how our iterative, lean and efficient approach to product development, clinical validation and regulatory affairs can help your organization get its MedTech solutions to market and gain adoption.
Stay Connected with BML Health.
Connect with BML Health on LinkedIn.
