This knowledge hub serves as a home for educational resources on medical cybersecurity regulations, standards and best-practices, intended to help medical device manufacturers and their suppliers navigate the troubled waters of compliance.
Principles and Practices for Medical Device Cybersecurity
Guidance on Cybersecurity for Medical Devices
Premarket and Postmarket Management of Cybersecurity
Key Practices in Cyber Supply Chain Risk Management
OpenChain Specification for Open Source License Compliance
The International Medical Device Regulators Forum (IMDRF) principles and practices for medical device cybersecurity
Final version, released on March 18th 2020.
Medical Device Coordination Group Guidance on Cybersecurity for Medical Devices
Document MDCG 2019-16, rev.1 (July 2020)
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Draft Guidance - Document issued on October 18, 2018
Postmarket Management of Cybersecurity in Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff - Document issued on December 28, 2016
Key Practices in Cyber Supply Chain Risk Management: Observations from Industry (February 2021)
OpenChain ISO/IEC 5230 (also avaialble as OpenChain 2.1) is the international standard for open source license compliance