Connect design history, risk management, CAPA records, and field intelligence on one platform — where regulatory rigor meets engineering precision.
“I walked away from Jira and JAMA. I wanted a platform for traceability from user needs to validated features. Apiphany gives us a living trace matrix that builds itself as work gets done, without the manual upkeep.”
Extract failure modes from free-text comments and cluster them into patterns your dropdown categories were never designed to capture.
Connect current design activity to prior failures, root cause analyses, and resolutions from past programs — surfaced at the point of design.
Map risk controls to originating requirements and link them to FMEAs. Identify where controls are inconsistent or never implemented.
Compare specification revisions at the requirement level and map each delta to the downstream processes and validation activities it impacts.
Extract requirements from RFP documents and link them to prior program data, past estimates, and delivery outcomes to build proposals on institutional knowledge.
Ingest unstructured documents, notes, and legacy files, then extract requirements, test results, and risk inputs into structured QMS artifacts.
“Before we even make a prototype, the design folks use Apiphany in scenario planning for what could go wrong. We're learning from our previous mistakes.”
Bring together CAPAs, complaints, design history, and risk files into a single searchable record your whole team can act on.
Detect emerging patterns across nonconformances, field issues, and post-market data before they become audit findings.
Connect current design activity to historical lessons, prior failures, and resolved CAPAs so your team doesn't repeat known mistakes.
SOC 2 Type II, ISO 27001, HIPAA-aware, and 21 CFR Part 11 aligned. Your patient data stays protected.
Join leading medical device teams already using Apiphany to connect engineering data to quality outcomes.