21 CFR Part 820 — QMSR

The amended Part 820 incorporates ISO 13485:2016 by reference and replaces the QSR from 2 February 2026. Covers the structure of the QMSR, key differences vs. ISO 13485, and how to transition a QSR system.

Modules

20 modules

Category

Quality Management

Pass mark

80%

Certificate

Free, instant

Audience

U.S. medical device manufacturers, importers and specification developers preparing for the QMSR compliance date.

• Understand from QSR to QMSR
• Understand key Definitions and Differences vs. ISO 13485
• Understand transitioning a QSR System to the QMSR
• Understand design Controls Under the QMSR
• Understand medical Device Reporting (21 CFR Part 803)
• Understand corrections, Removals and Recalls (Part 806 and Part 7)
• Understand unique Device Identification (21 CFR Part 830)
• Understand electronic Records and Signatures (21 CFR Part 11)

• Build a compliant QMS

  Translate ISO requirements into practical procedures, records and controls for your organisation.

• Stay audit-ready

  Understand the exact clauses and expectations auditors and regulators check during inspections.

• Boost your career

  A recognised certificate of completion that you can add to your CV and LinkedIn profile.

• Plain-language modules

  Complex requirements broken into bite-sized, easy-to-remember lessons with examples.

• Free assessment & certificate

  Take the timed exam and earn a personalised, verifiable certificate at no cost.

• U.S. medical device manufacturers, importers and specification developers preparing for the QMSR compliance date

• 20 plain-language modules

  Bite-sized lessons with examples, memory aids and key terms.

• Timed assessment

  Multiple-choice exam with 80% pass mark. Retake anytime.

• Verifiable certificate

  Personalised PDF with a unique verification code — shareable on LinkedIn.

• Downloadable resources

  Reference material and attachments available inside modules.

• Lifetime access

  Learn at your own pace — revisit modules whenever you need to refresh.

• Aligned to standards

  Content mapped to internationally recognised medical device standards and regulations.

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