Adapted from US Food and Drug Administration (FDA)

Adapted by AhaSlides from public-domain training material published by the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA). These are not FDA materials, and the FDA does not endorse AhaSlides. 2 ready-made templates so far, each with a self-paced course, a live session deck and two surveys.

2 templates · Templates are a starting point, not legal advice

Templates

US federal
Ethics & Compliance Training
Medical device quality: The FDA Quality Management System Regulation
Quality and regulatory teams
Covers:
- Explain why the 1996 Quality System Regulation was replaced
- Describe the purpose and scope of the QMSR and who it covers
- Explain how the QMSR brings in an international standard by reference
Last reviewed Nov 2026
Adapted from US Food and Drug Administration (FDA)
30 minCourse · Live deck · 2 surveys
US federal
Ethics & Compliance Training
Medical device design and development controls under the FDA QMSR
Engineering and quality teams
Covers:
- Explain why design and development controls matter
- Trace how design controls became a requirement, from 1990 to 2026
- Say which manufacturers must meet the QMSR design
Last reviewed Nov 2026
Adapted from US Food and Drug Administration (FDA)
20 minCourse · Live deck · 2 surveys

Adapted from US Food and Drug Administration (FDA)

Templates

Medical device quality: The FDA Quality Management System Regulation

Medical device design and development controls under the FDA QMSR

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