Safety Seminar

Integrating IEC 60601 into the design process

IEC 60601, IEC/ISO 80601, Ed 3.2 Series, Medical Electrical Equipment, Basic Safety & Essential Performance

Objective

This course is an intense 3.5 day training course. Presentation slides contain excerpts from the applicable safety standards, and frequent examples to illustrate how the safety requirements apply to typical medical device designs. Participants are broken into work groups where they put newly learned safety requirements into practice with assigned exercises. The groups review their answers with the class. The slides and a work book is given to each participant. After the class, the work book with answers is given to participants. Our course continues to evolve to stay up to date with latest standards, interpretations, regulatory guidance, and feedback from over 1500 past participants. Participants are encouraged to ask questions about the safety requirements, and how they apply to their products currently under development.

The goals of the course are:

  • Practical application of requirements to typical medical device designs,

  • Applying new concepts in small group break out sessions,

  • Avoiding safety pitfalls,

  • Supporting regulatory requirements,

  • Integrating risk management, usability engineering, and test requirements into the design process,

  • Constructing insulation diagrams,

  • Identifying safety critical components and requirements, and

  • Documenting compliance to IEC 60601-1 using IECEE CB formatted test report forms.

Schedule

We'll set dates and locations when routine business travel resumes. Once scheduled, we'll be notifying those on our mailing list.

In the meantime, you may find our safety webinar of interest.