We provide help to Machinery and Medical Device Manufacturers to meet the requirement of CE Marking including risk management to EN ISO 14971 and machinery risk assessment to EN ISO 12100 ( which replaced EN ISO 14121-1). We can assist in finding the appropriate EC Directives and Harmonised standards, determine the tests required and help putting together the Technical File and the Declaration of Conformity or Incorporation. We offer help in Meeting the Essential Health and Safety Requirements of the Directives, helping to identify which Harmonised Standards apply, putting together yorur Technical File, and helping with the User and Mainteance Manuals and the appropriate labels for your equipment. We have worked in France, the USA and Canada, with companies in China and India and in many places in the UK. Contact David Baker to chat about what help you might need.