This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:
This highly interesting and informative course is designed for individuals who are seeking to extend their current risk management of medical devices knowledge further to incorporate and understand BS EN 62366 & BS EN 60601-1. Individuals must already have a good understanding of Risk Management using ISO 14971 and/or attended our Risk Management 1 – ISO 14971, 2-day course.
Risk Management using ISO 14971 for the design and manufacture of medical devices is a widely used internationally recognised standard. However Medical device manufacturers who produce complex electrical devices and incorporate user interfaces in their devices will need to extend the scope of their risk management activities beyond use of ISO 14971 to take account of the need to ensure electrical safety and reduce the risks associated with the potential misuse or misinterpretation of user interfaces.
This practical, 1 day workshop based course is full of case studies and has been designed to provide delegates with the skill and knowledge required to understand, interpret and apply BS EN 62366 and BS EN 60601-1 in their risk management of user interfaces and electrical equipment alongside ISO 14971, the international standard for risk management of medical devices. The course provides delegates with a range of tools and techniques that can be used as part of their on-going risk management activities.
years of successful work