regulations » IEC 62304
IEC 62304 Compliance

Meet IEC 62304 Requirements

Meet the software development lifecycle requirements of IEC 62304

If your medical device has software that regulates its functionality in a way that contributes to Basic Safety or Essential Performance, then you will need to comply with IEC 62304. The standard requires all aspects of the software development life cycle (SDLC) to be appropriately managed to ensure patient safety, including:
  • Development and code reviews
  • Risk management
  • Configuration management
  • Incident and bug resolution
  • Validation
  • Maintenance

IEC 62304 Management Solutions

All these SDLC activities generate a great deal of documentation that can be difficult to keep organized and readily available when they are needed. InfoStrength’s solutions, combined with the regulatory expertise of our consultants, allow you to implement your IEC 62304 SDLC management documentation for easier compliance, faster validation, and better process management – so you can meet your commercialization goals sooner. 

InfoStrength helps you meet IEC 62304 requirements by:
  • Easy yet controlled access to your most current relevant SDLC and other GMP procedures
  • Incident and bug management that is traceable to your validation package
  • Organizing IEC 62304 and other relevant tables
  • A secure collaborative environment between quality, regulatory and software development 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!