IEC 62304 Regulations

Meet SDLC Requirements

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 requirements. 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 interpret and keep organized and readily available when they are needed. We use LuminLogic’s solutions (our regulatory software) and our expertise to organize your IEC 62304 SDLC management documentation for easier compliance, faster validation, and better process management – so you can meet your commercialization goals sooner.

Meet IEC 62304 requirements with:

  • Easy yet controlled access to your most current relevant SDLC and other GMP procedures
  • Incident and bug management from identification to resolution validation
  • Organized 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

Our goal is to help you achieve easier compliance, more efficient validation and improved process management.


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