Section 524B made post-market cybersecurity a legal duty, not a nice-to-have. MedISAO membership is the FDA-recognized way to meet it — the registered ISAO that carries the second half of your MSI journey, so you stay compliant for the life of the device.
The post-market obligations 524B puts on you, carried by a registered ISAO with 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, not just noise.
Members who meet the FDA's postmarket conditions can be spared correction and removal reporting under 21 CFR 806 when vulnerabilities are found.
MedISAO is a registered ISAO with a Memorandum of Understanding with the FDA — the credibility signal your customers and reviewers recognize.
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 postmarket posture defensible year after year.
MedISAO is a registered Information Sharing and Analysis Organization operating under a Memorandum of Understanding with the FDA, built for the medical device community. It's how MSI closes the loop: the platform gets your device cleared; membership keeps it compliant across its entire lifecycle.
Coordinated vulnerability disclosure · Device-specific alerts · 21 CFR 806 relief · Training & guidance · FDA MOU
Approval is the start line. Membership is how you stay across it — every device, every year.
