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Nearly all medical devices tested to IEC 60601-1 Ed3 fail to comply with the standard requirements of the first submission. Just as many are rejected on their Risk Management File. In-depth knowledge of the standard is a must to mitigate this risk.
Failing compliance testing means redesigning the product and reworking the Risk Management File (RMF). The consequence is delayed market entry, lost sales, and high redesign costs, all of which can be avoided by learning about the standard requirements.
This course covers:
Technical requirements and safety philosophies
• The standardization process and the development history of the standard
• Standard family structure and transition times
• Safety requirements - with extra focus on differences between the second and third editions
• The most important news in Amendment 2, which was published in August 2020
• Test methods
After the course, you should have a good knowledge of the requirements that you as a manufacturer and your products must meet. This knowledge will help you minimize the risks of expensive development projects and to get your product to market faster.
The course is primarily aimed at those who work with the development of medical devices. The course may also be of interest to those who work as quality managers or with regulatory affairs.
To get the most out of the training, it is an advantage (but not essential) if you have read the standard and have some experience of design and safety requirements.
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