Medical Device Cybersecurity Regulations, Standards
and Best-practices

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.

International Medical Device Regulators Form

Principles and Practices for Medical Device Cybersecurity

Medical Device Coordination Group (MDCG)

Guidance on Cybersecurity for Medical Devices

U.S. Food and Drug Administration
(FDA)

Premarket and Postmarket Management of Cybersecurity

National Institue of Standards and Technology

Key Practices in Cyber Supply Chain Risk Management

ISO/IEC 5230
OpenChain Standard


OpenChain Specification for Open Source License Compliance

IMDRF

Principles and Practices for Medical Device Cybersecurity

IMDRF/CYBER WG/N60

The International Medical Device Regulators Forum (IMDRF) principles and practices for medical device cybersecurity
Final version, released on March 18th 2020.

EC MDCG

ec logo

MDCG 2019-16

Medical Device Coordination Group Guidance on Cybersecurity for Medical Devices
Document MDCG 2019-16, rev.1 (July 2020)

FDA Cybersecurity Requirements

FDA-2018-D-3443

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Draft Guidance - Document issued on October 18, 2018

FDA-2015-D-5105

Postmarket Management of Cybersecurity in Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff - Document issued on December 28, 2016

NIST Supply Chain Security

NISTIR 8276

Key Practices in Cyber Supply Chain Risk Management: Observations from Industry (February 2021)

ISO/IEC 5230 (2020) & OpenChain 2.1

ISO/IEC 5230:2020

OpenChain ISO/IEC 5230 (also avaialble as OpenChain 2.1) is the international standard for open source license compliance

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