One platform, priced per product line.
Medcrypt Security Intelligence is the compliance platform your device runs on. Build the premarket documentation, check it against what FDA actually flags, then keep it current for as long as the device is on the market. One subscription covers the software, SBOM and vulnerability management, and a standing advisory retainer with our former FDA reviewers, starting at $35,000 per product line, per year.
Includes 15 expert advisory hours · penetration testing available as a scoped add-on
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Readiness check
Free
See where your cybersecurity documentation actually stands before you commit to anything. A scored gap report across the domains FDA reviews, in about ten minutes.
The platform
MSI
Starting at
$35,000
per product line / year
The full compliance platform for one product line, plus 15 hours a year with our regulatory experts. Premarket documentation, submission audit, SBOM and vulnerability management, and postmarket monitoring that continues after you clear.
Compare in detail
| Feature | Readiness checkFree | MSIFrom $35,000 / product line / yr | EnterpriseCustom |
|---|---|---|---|
| Platform | |||
| Product lines covered | Not included | 1 | Multiple |
| Free readiness check | Included | Included | Included |
| Users | Unlimited | Unlimited | Unlimited |
| Check your work | |||
| eSTAR readiness check | Included | Included | Included |
| Cybersecurity maturity assessment | Basic | Full | Full |
| FDA submission audit | Not included | Included | Included |
| Gap assessment report | Not included | Included | Included |
| Deficiency letter (AINN) response | Not included | Included | Included |
| Build it right | |||
| Guided threat modeling | Not included | Included | Included |
| Cybersecurity risk assessment | Not included | Included | Included |
| Requirements workbench | Not included | Included | Included |
| Regulatory intelligence search | Not included | Included | Included |
| Document generationBeta | Not included | Included | Included |
| Postmarket | |||
| Helm SBOM and vulnerability management | Not included | Included | Included |
| Continuous vulnerability monitoring | Not included | Included | Included |
| MedISAO membership | Not included | Included | Included |
| Expert services | |||
| Expert advisory hours | Not included | 15 hrs / year included | Custom volume |
| Penetration testing | Not included | Add-on | Add-on, custom scope |
| Additional advisory hours | Not included | Add-on | Add-on |
| Expert submission review | Not included | Add-on | Add-on |
| Deficiency response support | Not included | Add-on | Add-on |
| Enterprise controls | |||
| Portfolio compliance dashboard | Not included | Not included | Included |
| Custom requirements layer | Not included | Not included | Included |
| Configure your own model | Not included | Not included | Included |
| Self-hosted deployment | Not included | Not included | Included |
| SSO / SAML | Not included | Not included | Included |
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