Product Security & Engineering
The work that makes an incident boring happens beforehand.
You already know which devices are affected
The first hours of an incident usually go on working out which products and versions ship the broken component. With the SBOM inventory already in place, that question is a query rather than an investigation.
The reporting duty has a clock on it
Section 524B put postmarket obligations on connected devices, and a coordinated disclosure runs against a deadline you don't control. Tracking each report through intake, assessment, fix, and disclosure means the deadline is a date on a board rather than a discovery.
The response starts written
Affected versions, the customer notice, and the regulatory wording arrive as drafts built from what the platform already knows about the device. You approve and send rather than starting from a blank page at the worst possible moment.
Industry coordination · MedISAO
The platform tracks your own disclosures. Coordinating across the device industry is what MedISAO does: weekly vulnerability advisories, a turnkey coordinated disclosure program, and Medcrypt’s FDA-recognized ISAO, operating under a CDRH Memorandum of Understanding since 2018. Membership starts at $1,200 per year.