Courses
Choose a course and work through the lessons at your own pace.
10lessons1 h 26 minof video
ISO 13485:2016
Foundations for the Quality Manager role
How a quality management system works day to day in a small medical-device company, from processes and records to audits and CAPA.
10lessons1 h 26 min
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Lesson 1: QMS Processes and the Quality Manager Role
9:55 · 11 chapters · 10 questions -
Lesson 2: Document and Record Control
8:43 · 11 chapters · 10 questions -
Lesson 3: Management Responsibilities and Review
8:33 · 11 chapters · 10 questions -
Lesson 4: Competence and Training
8:34 · 11 chapters · 10 questions -
Lesson 5: Risk and Design-Control Interfaces
8:52 · 11 chapters · 10 questions -
Lesson 6: Supplier and Purchasing Controls
8:26 · 11 chapters · 10 questions -
Lesson 7: Production and Measuring-Equipment Controls
8:25 · 11 chapters · 10 questions -
Lesson 8: Feedback, Complaints and Reporting Escalation
8:23 · 11 chapters · 10 questions -
Lesson 9: Internal Audit Coordination
8:08 · 11 chapters · 10 questions -
Lesson 10: Nonconformances, Data and CAPA
8:26 · 11 chapters · 10 questions
QMSR
FDA's Quality Management System Regulation
21 CFR Part 820 as revised by FDA's 2024 Final Rule, re-presented from FDA's CDRH Learn presentations.
3lessons58 min
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Lesson 1: FDA QMSR Overview
15:25 · 11 chapters · 10 questions -
Lesson 2: Navigating FDA QMSR
19:42 · 13 chapters · 10 questions -
Lesson 3: QMSR Risk Management and Risk-Based Decisions
22:36 · 16 chapters · 10 questions
MDR
Medical Device Reporting
What manufacturers need to recognize, record and escalate under 21 CFR Part 803.
1lesson9 min
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Lesson 1: Medical Device Reporting Awareness
8:55 · 11 chapters · 10 questions