CE Mark Requirements
Stay compliant as you build your device
Automate compliance with ISO 13485 & get to market faster with 510(k), MDR, and MDSAP frameworks.
EU MDR (EU 2017/745)
ISO 13485:2016
Medical Device Design & Manufacturing
ISO 14971:2019
Risk Management
MDSAP
Medical Device Single Audit Program
QMSR
FDA Medical Device QMS Requirements
IEC 62304:2006
Software Life Cycle Processes
ISO 27001:2022
InfoSec & AI Governance
510(k)
Substantially Equivalent Device Requirements
How it works
Compliant design & development from day 1
Out-of-the-box compliance with ISO 13485.
Collaborate & track progress
Guided remediation flows for non-quality & non-technical experts
Unlock geographies faster
Faster readiness for CE Mark, FDA approval, and MDSAP.