Certify helps to identify the regulatory and standard requirements applicable to your medical device and automatically generates the corresponding risk controls and technical requirements.
It fully complies with the methodologies defined by ISO 14971 and IEC 62366, producing standards-compliant reports aligned with the expectations of testing laboratories, notified bodies, and auditors.
Thanks to real-time end-to-end traceability — from normative requirements to objective evidence of compliance — Certify enables instant impact analysis for any change.
Designed for SaMD, Certify supports manufacturers in applying IEC 62304, including lifecycle structuring and compliant reporting.
Optimize, control, and continuously maintain your certification process with a single, integrated platform.
Secure, always available, and continuously updated — powered by Microsoft Azure.
