Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Acronyms
4 HFE/UE Integration within existing
DESIGN CONTROLS
5 Pre DESIGN CONTROLS
6 DESIGN CONTROLS - General
[21 CFR 820.30(a)(1)]
7 Design and development planning
[21 CFR 820.30 (b)]
8 DESIGN INPUT [CFR 820.30 (c)]
9 DESIGN OUTPUT - [21 CFR 820.30 (d)]
10 Design reviews - [21 CFR 820.30 (e)]
11 Design VERIFICATION - [CFR 820.30 (f)]
12 Design VALIDATION - [21 CFR 820.30 (g)]
13 Design transfer - [CFR 820.30 (h)]
14 Design changes - [CFR 820.30 (i)]
15 DESIGN HISTORY FILE - [CFR 820.30 (j)]
16 POST-MARKET SURVEILLANCE
ANNEX A (INFORMATIVE) - HFE/UE report
Bibliography