MedISAO is the FDA-recognized ISAO that keeps your devices compliant after clearance — coordinated vulnerability disclosure, device-specific intelligence, and 21 CFR 806 relief. Now included with every MSI subscription, so you meet Section 524B at the speed the threat landscape is actually moving.
operating under an FDA Memorandum of Understanding
MOU renewed by FDA's Center for Devices and Radiological Health
dedicated to medical device manufacturers
Two things happened at once. Membership is how you answer both.
AI has collapsed the time between a disclosed CVE and a working exploit, and lets adversaries probe entire device fleets at scale. The window to detect, triage, and disclose keeps shrinking.
Regulators are modernizing how they review and monitor, and the bar for post-market programs rises with it. A documented, actively-run program is increasingly the expectation, not the exception.
Spreadsheets and once-a-year reviews weren't built for this pace. Keeping up now means continuous, machine-speed monitoring tied to the devices you actually ship.
The post-market obligations Section 524B puts on you, carried by a registered ISAO operating under a Memorandum of Understanding with the FDA.
524B requires a coordinated vulnerability disclosure process. Membership gives you a working CVD program from day one — not a policy you have to stand up yourself.
Customized alerts from a medical-device-specific vulnerability database, tied into Helm so a new CVE becomes a prioritized action instead of noise.
Members who meet the FDA's post-market conditions can be spared correction and removal reporting under 21 CFR 806 when vulnerabilities are found.
Vulnerability analysis is LLM-enhanced through Helm — the same engine inside MSI — so threat data and guidance changes reach you as they happen, mapped to the devices they affect.
MedISAO is a registered Information Sharing and Analysis Organization with an FDA MOU — the credibility signal your customers and reviewers recognize.
High-quality training, tools, and a community of medical-device peers to learn and share best practices in a field that changes every quarter.
Activate membership and connect your device portfolio. Your CVD program and alert feeds go live immediately.
Receive device-specific vulnerability alerts and route disclosures through the coordinated program the FDA expects.
Guidance updates, training, and documented participation keep your post-market posture defensible year after year.
MedISAO is a registered Information Sharing and Analysis Organization operating under a Memorandum of Understanding with the FDA — signed in 2018, renewed in 2024, and published on FDA.gov. It's how MSI closes the loop: the platform gets your device cleared; membership keeps it compliant across its entire lifecycle.
Explore the knowledge center, and catch the "Navigating Risk Management for Medical Devices" series — all four sessions are available on demand as recordings.
Guidance changes, alerts, and community updates — dated, so you can see we're on it.
Approval is the start line. Membership is how you stay across it — every device, every year, at the speed the threat landscape is moving.