ABSTRACT:
The pace of release of cybersecurity guidance for medical devices across the globe has been accelerating over the past few years. Compliance and legal officers, CIOs, and CSOs working for multinational Medical Device Manufacturers (MDMs) and/or Health Delivery Organizations (HDOs) are tasked with interpreting these guidelines; this review is intended to help them navigate the complex landscape.
A Summary of Global Guidance
This report provides a summary of guidance documents and directives from major global regulatory bodies, including the United States, European Union countries, Canada, Australia, and Japan. Some regulatory bodies have restricted their guidance to premarket concerns and others have provided guidelines to include postmarket considerations as well.
First in a Four Part Whitepaper Series
This report represents the first in a series on medical device cybersecurity compliance and focuses on providing a landscape overview of medical device cybersecurity guidance. Future parts in this series are planned to include a cross-comparison of convergences and trends and specific expectations on standards. The last edition is expected to include a series of interviews with global regulators in order to gain their perspective on market challenges and how the new regulations can help guide industry
