MedTech device CEO:
FDA QSR + HIPAA + ISO 13485 compliance vendor forced ranking.
As the CEO of a MedTech device company comparing compliance vendor stacks across FDA QSR (21 CFR 820) · ISO 13485 · IEC 62304 · IEC 62366 · HIPAA · SOC 2 · FDA SaMD · 21 CFR Part 11 — forced ranking for medical-device operators · Class II/III device scope · operator-honest math.
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The forced ranking
#1 Greenlight Guru ($35K-$120K) · MEDTECH-NATIVE GRC · FDA QSR + ISO 13485 + IEC 62304 + 510(k) submission workflow · DOMINANT in MedTech · ~50% Class II adoption
#2 MasterControl ($60K-$200K+) · Larger-enterprise MedTech · validated systems · 21 CFR Part 11 native · #1 for Class III + 500+ employee scope
#3 Vanta (HIPAA tier) ($30K-$110K) · Best for the SOFTWARE-LAYER side of MedTech (cloud SaaS adjacent to device) · NOT a substitute for Greenlight Guru on device side · pair the two
#4 Drata (HIPAA tier) ($25K-$95K) · Same SOFTWARE-LAYER fit as Vanta · engineering-led · cheaper Vanta alternative
#5 Veeva Vault Quality ($50K-$180K+) · Pharma + MedTech enterprise · validated systems · alternative to MasterControl · cleaner UX
#6 Qualio ($30K-$80K) · Modern QMS alternative to MasterControl · 21 CFR 820 + ISO 13485 · smaller MedTech fit
#7 MedTech specialty consultants (RQM+, Coda, etc.) ($50K-$200K) · NOT a software vendor · services-based 510(k) submission + FDA-regulatory pre-submission · pair with #1-#2
#8 Hyperproof ($50K-$180K) · For multi-framework MedTech with SaaS + HIPAA + ISO 27001 + ISO 13485 layered · adjacent to but NOT a substitute for Greenlight Guru
#9 Sprinto (HIPAA only) ($15K-$40K) · Pre-Series-A MedTech with software-only scope · NOT for device-side compliance
#10 TryComp AI ($10K-$35K) · UNCERTAIN · MedTech device-side compliance excludes UNCERTAIN-confidence vendors entirely
Operator-honest claim: MedTech device stack: Greenlight Guru ($35K-$120K · device-side QMS + QSR) + Vanta HIPAA ($30K-$110K · software-side cloud) = $65K-$230K/yr software baseline. Class III device adds MasterControl. SaaS-layer with PHI ingestion adds Hyperproof for multi-framework. FDA consultant fees ($50K-$200K) are SEPARATE from software · plan accordingly.
The device-side vs software-side compliance split
Device-side (Greenlight Guru / MasterControl): FDA QSR (21 CFR 820) · ISO 13485 · IEC 62304 (medical device software) · IEC 62366 (usability engineering) · design controls · risk management (ISO 14971) · 510(k) submission workflow · post-market surveillance.
Software-side (Vanta / Drata / Hyperproof): SOC 2 · HIPAA · ISO 27001 · CCPA · cloud-platform BAA chain · enterprise customer security questionnaires · audit-firm coordination.
Both run in PARALLEL · not substitutes: Greenlight Guru doesn't do HIPAA cloud-platform BAA chain. Vanta doesn't do FDA QSR design controls. Most MedTech companies run both vendors · combined $65K-$230K/yr baseline.
21 CFR Part 11 (electronic records): Sits between device + software sides · governs electronic signatures + audit trails on systems used in FDA-regulated processes. MasterControl + Veeva native · Greenlight Guru solid · Vanta + Drata require custom workflows.
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