Foreword
Introduction
1 Scope
2 Terms and definitions
3 Symbols and abbreviations
4 Outline of the issues
5 General position on medical device controls
6 The border between health software products and medical
   devices
7 Classifying health software products
   7.1 Options
   7.2 Conclusions
8 Options for control measures for health software products
   8.1 General
   8.2 Labelling and documentation
   8.3 Clinical evidence
   8.4 Incident reporting
   8.5 Quality Systems
   8.6 Design control
   8.7 Risk management
9 Standards specific to risks of a particular nature
   9.1 Conclusions
10 Observation on safety and risks in the user domain
   10.1 Conclusions
11 Taxonomies
   11.1 Conclusions
12 Summary of conclusions
Annex A (informative) Position regarding medical devices in
        different countries
      A.1 The EU, Australia and Canada
      A.2 USA
      A.3 The Global Harmonization Task Force (GHTF)
Annex B (informative) Analysis of classification procedures
      B.1 EU, Australian, Canadian and GHTF Medical Device
          Classification
      B.2 USA Medical Device Classification
      B.3 USA FDA guidance related to software classification
      B.4 CEN classification of health software products
      B.5 Conclusions
Annex C (informative) Risk management
      C.1 Attributes necessary for successful uptake of risk
          management processes
      C.2 Minimum components for an effective risk management
          process
      C.3 'Enterprise risk management' processes
      C.4 'Healthcare related' risk management standards
      C.5 Related risk management standards
      C.6 Overall conclusions regarding risk management standards
Bibliography