Approving medical devices can be a complicated and time consuming process with ever changing requirements. The workshop is intended to guide you through that process and will cover the testing aspects of IEC 60601-1, general risk management, the role of risk management in the new medical EMC standard, usability and functional safety. We will conclude with a top level look at the Medical Devices Directive, ISO 13485 and Notified Body activities bringing all the previous topics together.
If you are involved with active medical devices, particularly in design and development, compliance and approvals, quality and regulatory affairs or bringing products to market then this workshop will be invaluable.
You will have the opportunity to meet with key experts from our medical team who will be on hand to discuss and advise on any aspects with one to one sessions also being available (by prior arrangement).
Attending this workshop will help you to understand the compliance requirements for active medical devices. This workshop will give you the best opportunity to get your compliant devices to market on time, every time.