Accelerate your regulatory outcomes by 80%
Built-in regulatory compliance from day one
No more assembling compliance packages by hand at the end for audits and submissions. Qualio has clause-level regulatory requirements baked in so you can put compliance on autopilot.
20+ standards supported & always growing
GMP & Clinical Compliance
- 21 CFR Part 210/211
- ICH E6
- ICH Q7–Q11
- ISO 9001:2015
Computerized Systems
- 21 CFR Part 11
- EudraLex Vol 4
- EU GMP Annex 11
Medical Devices & Software
- EU MDR
- ISO 13485
- ISO 14971
- MDSAP
- QMSR
- IEC 62304
- 510(k)
InfoSec & AI Governance
- ISO 27001
- ISO 27701
- ISO 42001
Biologics & Labs
- 21 CFR 1271
- AATB
- ISO 15189
- ISO/IEC 17025
How it works
- Step 1: Activate your frameworks
- Step 2: Qualio maps policies & evidence
- Step 3: Monitor risks
