MDS2 form
The manufacturer disclosure statement for medical device security, for every shipping device.
Security and compliance: the documentation exists before you ask for it.
A security review is going to ask these questions anyway. This page lists what we have, how to get it, and what we will not claim.
- Development process
- Aligned to IEC 81001-5-1
- Per device
- MDS2 form and SBOM per firmware version
- Hosting
- SOC 2 Type II report, annual
- Disclosure
- Coordinated, published policy
- Penetration testing
- Independent, annual, per product
Product security
How devices and firmware are built and maintained.
Secure development
Threat modeling at design, security requirements traced to tests, and code review on every change to a safety or security function.
- IEC 81001-5-1 aligned lifecycle
- Static and dynamic analysis in every build
Software bill of materials
Every firmware version ships with an SBOM in SPDX and CycloneDX formats, and we monitor every component in it.
- Published per release
- Third-party components tracked to end of support
Device identity
Each device carries a unique certificate from manufacture, and talks only to infrastructure it can authenticate.
- Mutual TLS 1.3
- Hardware-protected keys
Patching
Security fixes are delivered through Formcloud with the same staging controls as any other update.
- Critical fixes within 30 days of confirmation
- Customer notification through advisories
Hosting and data
For Nexaform-hosted Formcloud tenancies.
| Control | What we do |
|---|---|
| Audit report | SOC 2 Type II, issued annually; available under NDA |
| Information security | ISO/IEC 27001 certified management system |
| Encryption | TLS 1.3 in transit; AES-256 at rest with per-tenancy keys |
| Access | SAML 2.0 and OIDC single sign-on; SCIM 2.0; role-based access |
| Health data | Business associate agreement available for US customers |
| Residency | US, Canada, EU or UK; data does not leave the chosen region |
| Backups | Encrypted, in-region, tested quarterly |
The review pack
One request gets all of it. Most of it is under a standard mutual NDA.
Software bill of materials
SPDX and CycloneDX, for every firmware and Formcloud release.
SOC 2 Type II report
For Nexaform-hosted Formcloud.
Penetration test summaries
Independent testing per product line, with remediation status.
Security architecture overview
Data flows, trust boundaries and key management, in about twenty pages.
Vulnerability disclosure policy
How to report an issue, what we commit to, and how we publish.
Reporting a vulnerability
If you believe you have found a security issue in a Nexaform product, write to security@nexaformlabs.com. We acknowledge reports within two business days and keep you updated until the issue is resolved.
We do not take legal action against good-faith research that follows the policy. We publish an advisory for every confirmed vulnerability, and we credit the reporter if they want to be credited.
Starting a security review?
Ask for the review pack on day one. It usually answers most of a standard questionnaire before the first meeting.