IEC 81001-5-1 Cybersecurity for Medical Devices

Learn the requirements of IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security.

The MDR requires that software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.  Today, IEC 81001-5-1 is considered that state of the art for cybersecurity within the development lifecycle. Additionally, on September 27, 2023, the FDA issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. In it, the FDA recommends implementation and adoption of a “Secure Product Development Framework” or “SPDF”. IEC 81001-5-1, a reference standard for health software, is an ideal framework to consider.

Key Topics

• Overview of 81001-5-1
• Relationship with IEC 62443-4-1
• Medical Software Classification
• Regulatory pathways
• Types of 81001-5-1 submissions
• Preparing a submission
• 81001-5-1 Review Process
  • Steps and timelines
  • Interacting with the vendor during the review process
  • Responding to Requests for Additional Information
• Case studies and best practices
  
  

Educational goals

After this course, participants will have a comprehensive understanding of 81001-5-1 as well as how to categorize health software in preparation for submission a third-party assessor, enabling them to effectively prepare, submit, and navigate regulatory requirements for medical software SPDF.

Target group

This course is intended for quality and regulatory professionals working with medical devices, medical device company management and employees who need to learn more about IEC 81001-5-1 and SPDF.

Upcoming classes

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