A hospital's security team wants paperwork before it will buy
FDA clearance gets your device to market. The hospital's security review decides whether it gets bought. Health delivery organizations send security questionnaires, ask for an MDS2 form, a recent penetration test, an SBOM, and evidence of HIPAA, SOC 2, or HITRUST controls. We help MedTech teams answer those reviews with evidence the hospital's security team will accept, so the deal keeps moving.
A single, parallel-track program that delivers FDA cybersecurity clearance plus the SOC 2, HIPAA, HITRUST, and GDPR evidence Hospital & Health-System (HDO) procurement teams and EU regulators require - so your commercialization isn't blocked after FDA approval.
Explore service PremarketHIPAA-aligned penetration testing for covered entities, business associates, and MedTech companies handling ePHI.
Explore service PremarketSOC 2 Type II readiness, control build, and audit support for MedTech SaaS, SaMD, and connected-device back-ends - aligned with your FDA cybersecurity program so one control set produces evidence for both.
Explore service PremarketHITRUST CSF readiness at the right level (e1, i1, or r2) for medical device and digital health companies - with MyCSF scoping, control build, and validated assessment support through an authorized External Assessor.
Explore serviceFree 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.
