Learn the requirements of IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security.
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. 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.
Key Topics
- Overview of 81001-5-1
- Regulatory Pathways
- Types of 81001-5-1 submissions
- Preparing a submission
- 81001-5-1 Review Process
1. Steps and timelines
2. Interacting with the vendor during the review process
3. 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.
Instructors
- Shiva Mokhberi, Technical Sales Manager
- Nick Thomas, IT Security Specialist
Shiva is an experienced technical professional in the life sciences and medical device industry with a strong background in regulatory compliance, product testing, and global market access. She led and supported testing projects for a wide range of medical and laboratory equipment in accordance with key international standards such as IEC 60601-1, IEC 61010-1, ISO 14971, IEC 62366, and IEC 62304.
Nick Thomas is an accomplished IT Security Specialist with four years of expertise in critical domains. His experience spans IEC 62443, the payment card industry, ISO 20243 supply chain, and IEC 81001-5-1 evaluations. Nick is a participant in the 62443 working group alongside Joe, he also holds a voting seat on the SEMI council.
Language
English
Upcoming classes
Please note:
Intertek operates under strict standards of independence, impartiality, and integrity. Read more about how we work here: https://www.intertek.com/about/compliance-governance/
