regulations » IEC 60601-1
IEC 60601-1 3rd Edition A1 Compliance

Provide structure to your medical device 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. InfoStrength’s solutions and MethodSense's regulatory expertise provide structure to your product documentation for easier compliance, faster validation, and better process management – so you can meet your commercialization goals sooner. 

InfoStrength helps you meet IEC 60601-1 3rd Edition A1requirements by:
  • Easy, yet controlled, access to your most current relevant risk management and other GMP procedures 
  • Organizing IEC 60601-1 and other relevant tables
  • A secure collaborative environment between quality, regulatory and engineering personnel with the appropriate document management and version controls to enable a smooth work process
  • A portal with role-based security to exchange content efficiently and conveniently with your Notified Body
Contact us today to ensure your device gets to market quickly and without unnecessary delay!