Medical device FMEA software

FMEA is one technique inside the ISO 14971 process. Tacit AI builds source-linked FMEA content and keeps it connected to the risk file as post-market evidence arrives.

Deployment, access controls, audit trail, electronic signatures and validation are set with your Quality, Regulatory and IT owners. Full audit trail, RBAC and MFA through your identity provider come standard. Integration follows your CSV procedures, and Tacit AI provides the IQ/OQ/PQ support documentation.

Every corrective action and design or process change is linked to the risk controls, verification evidence and analyses it affects. Your team assesses whether a CAPA changes the risk profile. Effectiveness verification and change approval remain in the manufacturer’s quality system.

Medical device risk management is product-centric and lifecycle-driven: design inputs, verification, manufacturing controls, complaints, and post-market surveillance all feed the same risk management file. Pharma process FMEA focuses on batch manufacturing steps. The workflows, standards (ISO 14971 vs ICH Q9), and regulatory expectations (QMSR vs cGMP) are fundamentally different. Tacit AI handles both natively.