FDA Medical Device Cybersecurity: Understanding Your Basic Regulatory Requirements

Medical Device CybersecurityA cyber-attacker gains access to a care provider’s computer network through an e-mail phishing trap and assumes command of a file server to which a heart monitor is attached. While scanning the network for devices, the attacker takes control (e.g., power off, continuously reboot) of all heart monitors in the ICU, putting multiple patients at risk.

It defies logic why a hacker would want to intentionally harm patients, but this type of threat is definitely not science fiction. It is one example of the risks that connected devices pose to patient safety according to a recently published paper by the US Department of Health and Human Services (HHS), which oversees FDA.…

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6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months

2019 JourneyThe next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year.

1 – Internal audits and gap assessments

The new European medical device and in vitro diagnostic regulations (EU MDR and EU IVDR, respectively) will certainly demand more attention from regulatory professionals in 2019.…

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FDA and EU Risk Requirements for Medical Device Software & SaMD

This is the first in a two-part blog series on risk management for medical device software. In our next post we take a look at the specific FDA and European risk requirements.

Software as Medical DeviceIn our first post we talked about international risk management standards and guidance applicable to medical device software, including the ISO 14971 and IEC 62304 standards. In this post we will discuss specific compliance requirements in the US and Europe for medical device software paired with hardware, and stand-alone Software as a Medical Device (SaMD).…

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Overview of Risk Management for Medical Device Software & SaMD

Medical Device SoftwareSoftware itself is not risky. Nobody gets directly injured by bad code or a poorly designed UI and, unlike hardware, software does not fail randomly.

That being said, software can definitely expose someone to a hazardous situation because software is viewed to have 100% probability of failure when it does occur. Therefore, this makes software rightfully subject to risk management oversight, including special considerations for software-controlled medical devices.

In this post, we’ll cover the basics of risk management for embedded software or stand-alone Software as a Medical Device (SaMD), so you have an understanding of what is required before, during, and after coding.…

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