Study Path Agent Study Path Agent
Generate Your Own
Risk management in medical devices
23 topics across 5 chapters
Chapter 1
Regulatory landscape for medical devices
1
FDA risk management expectations for medical devices
2
Global regulatory landscape (FDA, MDR/IVDR, harmonized standards)
3
Quality System Regulation (QSR) and 21 CFR 820 overview
Chapter 2
ISO 14971 risk management framework
4
Risk analysis concepts within ISO 14971
5
Risk evaluation and acceptability criteria
6
Risk controls and risk reduction strategies
7
Risk management file and documentation
Chapter 3
Hazard identification and risk analysis
8
Hazard identification techniques
9
Failure Mode and Effects Analysis (FMEA) in medical devices
10
Fault Tree Analysis (FTA) for complex devices
Chapter 4
Risk controls and verification/validation
11
Implementation of risk controls in design and process
12
Verification activities for risk controls
13
Validation of safety claims and performance under normal use
Chapter 5
Usability, human factors, and post-market surveillance
14
Usability engineering for risk reduction
15
Human factors validation in device development
16
Post-market surveillance planning and analytics
17
Corrective actions and field actions processes

Want a personalized study path for any topic?

Generate Your Own Study Path