FDA Cyber-Security Guidance For Medical Devices

Cybersecurity in the Medical Device Industry

Cybersecurity threats to medical devices are a developing concern in the industry. The manipulation of cybersecurity susceptibilities pose a risk to the safety and efficiency of medical devices. Manufacturers can integrate parts in the product designs for risks prevention, however, it is important that manufacturers consider maintenance improvements of the devices as well. These improvements are vital due to  the progressing nature of cyber threats which means that risks may increase all throughout a device’s lifecycle.

The FDA Guidance

In January 2016, the U.S. Food and Drug Administration (FDA) published a guidance draft that includes important steps that should be taken by medical device manufacturers in order to frequently address cybersecurity risks. These steps are crucial so that  patients are kept safe and that public health is maintained. According to the FDA, “The draft guidance, Postmarket Management of Cybersecurity in Medical Devices, details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.” The guidance draft is part of the FDA’s ongoing efforts to guarantee the safety and success of medical devices, at all of their lifecycle stages, in the midst of probable cyber threats.

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Years of experience coupled with dedication to service ensures that your organization will achieve medical device compliance when partnering with Arbour Group. We believe in a holistic approach that delivers extensive regulatory expertise and proven methodologies to ensure long term success in the medical device industry. Contact us today to learn how Arbour Group can help with your regulatory compliance needs.