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.
Premarket and Postmarket Management of Cybersecurity
Principles and Practices for Medical Device Cybersecurity
Guidance on Cybersecurity for Medical Devices
Key Practices in Cyber Supply Chain Risk Management
An ISO standard for open source license compliance
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff Document issued on April 8, 2022.
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Draft Guidance - Document issued on October 18, 2018
Postmarket Management of Cybersecurity in Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff - Document issued on December 28, 2016
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)
The proposal for a regulation on cybersecurity requirements for products with digital elements, known as the Cyber Resilience Act, bolsters cybersecurity rules to ensure more secure hardware and software products.
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