The medical device industry is the most heavily regulated in manufacturing, for good reason. Devices that do not meet the highest quality and safety standards present a risk of injury, recalls, embargos, bans and liability.
The transition from IEC 60601-1 2nd Edition to the 3rd introduced the concept and application of risk management in the design and production of these devices and it is imperative for everyone involved with product design to fully understand how the process of risk management is utilized by 60601-1 3rd Edition to achieve compliance. Gain an in-depth understanding of the international IEC 60601-1 3rd Edition standard and explore the applicable requirements, risk management and ISO 14971 concepts, construction requirements, and performance testing methodologies in an engaging and interactive classroom environment.
The course is comprised of two separate training modules: an eLearning component and the two-day instructor-led session. The eLearning component provides a foundational understanding of the overall structure and general concepts outlined in IEC 60601-1 3rd Edition. The online course is completed in advance, enabling participants to maximize their in-class time with our UL expert. The instructor-led session digs deeper into the detailed technical content and features progressive knowledge checks to help learners reinforce and apply the new concepts.
Upon completion of this seminar, participants should be able to:
- Recognize the full scope of IEC 60601-1, including the current deviations:
- US (ANSI/AAMI ES 60601-1:2005 (Revised 2012))
- Canada (CAN/CSA-C22.2 NO. 60601-1:14)
- Europe (EN 60601-1:2006 +A1:2013)
- Determine the applicable medical equipment requirements to design products for compliance
- Define insulation parameters and requirements
- Generate diagrams that determine creepage, clearance, insulation thickness and dielectric strength requirements
- Determine appropriate grounding / earthing, fire protection and mechanical requirements
- Create accurate and concise design and purchase specifications for critical components to achieve safety compliance goals
- Identify performance testing
A final assessment will be provided that requires participants to review requirements and recognize key concepts and applications
- Product safety engineers
- Compliance engineers
- Product designers
- Regulatory approval staff
- Production support engineers
- Quality assurance staff
- Technical marketing professions
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