Overview: The ISO 14071 standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485.Why should you Attend: There are outstanding tools in the ISO 14971, but they are not used adequately by many medical device companies. Most companies use only one or two tools out of the five tools. The most important tool, the Preliminary Hazard Analysis, is hardly used. A company with a high risk device must use all the five tools. This webinar will show how to use all five tools with a return on investment of at least 1000%. Areas Covered in the Session:Overview of ISO 14971:2012 standard, definitions and termshow to conduct risk management activities to remain compliant.GHTF Guidance "Implementation of Risk Management Principles and Activities within a Quality Management System."Lifecycle of RiskWho Will Benefit:R&D Managers and EngineersProduct Development Managers and EngineersRegulatory Affairs ProfessionalsQuality Assurance professionals involved in design and/or manufacturingClinical professionalsProduction Management professionalsPersonnel involved in risk assessment and Risk Management activities