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Quality Management System Regulation (QMSR) Training is a resource from the FDA that supports medical device manufacturers in understanding and implementing updated CGMP requirements. Effective February 2, 2026, the QMSR amends 21 CFR Part 820 to incorporate ISO 13485:2016, harmonizing FDA requirements with international standards used by other regulatory authorities worldwide.
The regulation applies to finished device manufacturers who commercially distribute medical devices, including accessories classified as finished devices. Eligible stakeholders include FDA staff, regulated industry participants, and stakeholders involved in medical device quality management.
Training and compliance resources are provided to help organizations align their quality systems with the updated inspection framework under Compliance Program 7382. 850.
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Or search similar grants →According to the current listing, eligibility includes: FDA staff and stakeholders involved in medical device regulation. Confirm the full requirements in the official notice before applying.
Quality Management System Regulation (QMSR) Training is funded by FDA. Verify program details on the funder's official page before applying.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.