Quality Training
Integrating IEC 60601 into the Design Process
Objectives
This 2 day training programme will give participants in depth knowledge on integrating the medical electrical equipment safety standard series, IEC 60601, into the design process.
Presentation slides will contain excerpts from the applicable safety standards, and frequent examples to illustrate how the safety requirements apply to typical medical device designs, and pitfalls to avoid. Participants are encouraged to ask questions about the safety requirements, and how they apply to their products currently under development.
Content includes
Safety standards covered:
- Medical Electrical Equipment -- Basic safety and Essential performance (general), IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012 + A1-C1:2014 + A2:2019 (draft), Ed 3.1 and 3.2 (draft), including the US, Can, and EU differences
- Alarms, IEC 60601-1-8:2006 + A1:2012 + A2:2017/CD (draft)
- Home healthcare, IEC 60601-1-11:2015
- Emergency medical services (pre-hospital), IEC 60601-1-12:2014
Who should attend
The course is geared towards Technical design engineers, Compliance engineers, Regulatory/quality system specialists, Any staff responsible for medical device safety. There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful.Upcoming dates:
No training dates available at the moment.
Register your interest
Register your interest
Course
Integrating IEC 60601 into the Design Process
Training Days
2 days
Training Locations
Dublin, Galway, Limerick
Course Cost
Member: €800
Non-member: €1,065
* Cost quoted per person