Intertek, a leading global provider of quality and safety solutions, announces a new two-day seminar for medical device manufacturers. The seminar, titled “Safety and Risk Management Requirements of IEC 60601-1, 3rd Edition,” will be held on December 1st and 2nd in Boxborough, MA.
Compliance with the 3rd Edition of IEC 60601-1 will become mandatory for medical devices in 2012. New requirements for Risk Management necessitate manufactures to consider the development of their Risk Management File early in the product development cycle.
Intertek’s new training course will help manufacturers interpret the revised IEC 60601-1 3rd Edition standard – particularly the new Risk Management aspects of the regulations – and understand what actions need to taken to ensure compliance.
Course information and registration can be found at http://www.intertek.com/medical/electrical-safety-testing/iec-60601-1/event/.
Day one of the course focuses on technical requirements and safety philosophies. During this time attendees will get an understanding of the standard’s structure and philosophy. The course will review the requirements, test methods, and interpretations. Also included are a brief review of the standardization process, the development of IEC 60601-1- family, and current transitional times.
The second day will spotlight issues of risk management including all the steps the manufacturer must apply in order to fulfil the risk management requirements of IEC 60601-1, as well as new methods of risk analysis.
Attendees can attend one or both days of the course, depending on their requirements. If you book both sessions, you’ll receive a discount of $295! One-day attendance is $645 (either day). Two-day attendance is $995. If 2 or more delegates attend the same session from the same company, they will receive a 10% discount on the training cost!
The seminar will be held December 1 and 2 in Boxborough, MA
For further information, or to register for the seminar, visit http://www.intertek.com/medical/electrical-safety-testing/iec-60601-1/event/ or contact Roy Strunin at (978) 635-8558 or [email protected].
