Organize your Risk Management Program
For those who design or manufacture electromedical equipment, IEC 60601-1 3rd Edition A1 is one of the most important safety and performance standards to meet. The standard addresses critical safety issues, including the risk of electrical shock, fire hazards and mechanical hazards, such as entrapment risks.
Devices that must meet current IEC 60601-1 requirements include those which:
- Diagnose, treat, or monitor the patient under medical supervision
- Make physical or electrical contact with the patient
- Transfer energy to or from the patient; and/or
- Detect such energy transfer to or from the patient.
IEC 60601-1 Management Solutions
Meeting the requirements of 60601-1 3rd Edition documentation requirements can be extensive and difficult to interpret. We use InfoStrength’s solutions (our regulatory software) and our expertise to provide structure to your product documentation for easier compliance, faster validation, and better process management– so you can meet your commercialization goals sooner.
If you are currently in the very early design stages, now is the time to talk about the implications of IEC 60601. At this stage, we’ll work with you to provide IEC 60601-1 training for your engineering team. This training will guide the engineers in a way that allows them to:
- Think through – well in advance of being ready to submit the product for testing – the impact of the standard on their design ideas
- Engage in more cost effective redesign early on
- Keep project milestones and plans on track by avoiding redesigns due to safety testing failures
Our goal is to help you achieve easier compliance, more efficient validation and improved process management. Be prepared for your next FDA inspection – SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS TODAY.