2 Terms an definitions

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	04.04.2014 09:13:24
Modified:	18.01.2015 00:09:38

Diagram Elements :

ISO 14971 Requirements : ISO 14971 Requirements

2.28 Verification

2.27 Use error

2.26 Top management

2.25 Severity

2.24 Safety

2.23 Risk management file

2.22 Risk management

2.21 Risk evaluation

2.20 Risk estimation

2.19 Risk control

2.18 Risk assessment

2.17 Risk analysis

2.16 Risk

2.15 Residual risk

2.14 Record

2.13 Process

2.12 Procedure

2.11 Post-production

2.10 Objective evidence

2.9 Medical device

2.8 Manufacturer

2.7 Life cycle

2.6 In vitro medical device

2.5 Intended use

2.4 Hazardous situation

2.3 Hazard

2.2 Harm

2.1 Accompanying document