At the end of 2016, the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Medical Devices to inform industry of recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. This guidance emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits for their medical devices.
What is in the FDA Guidance Document:
This document highlights that it is essential for device manufacturers to implement comprehensive cybersecurity risk management programs. These programs should focus on addressing the vulnerabilities which could permit the unauthorized access, modification, misuse, or denial of use of information that is stored, accessed, or transferred from a medical device, and could impact patient safety.
Download the FDA Guidance Document: Postmarket Management of Cybersecurity in Medical Devices
Do you need help implementing the recommendations in this guidance document? Talk to our CSV experts about how we can help you can update your practices for compliance.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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