1 - Introduction (9.36 MB)
2 - What is ISO14971 (68.37 MB)
3 - Key Definitions and Concepts in ISO 14971 (42.57 MB)
4 - Competence of personnel (37.91 MB)
5 - Regulatory requirements (52.41 MB)
10 - Risk control (23.07 MB)
11 - Evaluation of overall residual risk (36.69 MB)
6 - Risk Management Process (12.83 MB)
7 - Risk Management Plan (37.64 MB)
8 - Risk Analysis (79.77 MB)
9 - Risk Evaluation (17.82 MB)
12 - Risk management review (35.44 MB)
13 - Production and postproduction activities (35.86 MB)