WYM-ACC-tatvam · Design Risk & DFMEA · formerly Pragna AI
Tatvam
tatvam - essence, the underlying principle of a thing
The whole failure-mode workflow in one control room, auditable end to end.
Tatvam is an AI-assisted DFMEA platform built for medical device and regulated product risk analysis. It brings the full failure-mode workflow into one control room: a product hierarchy tree, a working table for scoring risk, AI-generated failure-mode suggestions an engineer accepts or refines, a risk register comparing initial against residual RPN, and end-to-end traceability from requirements through functions and failure modes to tests. A traditionally spreadsheet-heavy compliance process becomes fast, structured, and auditable.
Initial vs residual
RPN compared in a sortable risk register
Audit-ready
traceability from requirement to test
Problem
DFMEA lives in spreadsheets, so risk scoring is inconsistent, failure modes are missed, and requirements-to-test traceability has to be reconstructed before every audit.
Outcome
A structured, auditable digital risk workflow from product hierarchy through failure modes, scoring, and verification test coverage.
How it works
01
Model the product
The hierarchy of systems, subsystems, and components is captured as the spine of the analysis.
02
Discover failure modes
Candidate modes are suggested from design context; the engineer stays the decision-maker.
03
Score the risk
Severity, Occurrence, and Detection are applied consistently, producing comparable RPN across the programme.
04
Trace to verification
Every requirement resolves to the failure modes it guards and the tests that verify them.
Bill of materials
This pack composes catalog agents. Same IDs as the rest of the catalog.
Pack Architecture & Agent Composition Graph
10 Composed Agents- AGT-0345
Quality Inspection Reporting Agent
Quality
- AGT-0348
Scrap and Rework Analysis Agent
Quality
- AGT-0349
First-Pass Yield Improvement Agent
Quality
- AGT-0360
Generative Engineering Design Agent
R and D
- AGT-0361
Patent Prior Art Search Agent
R and D
- AGT-0362
Materials Selection Agent
R and D
- AGT-0363
Failure Mode Analysis Agent
Quality
- AGT-0364
Simulation Setup Copilot
R and D
Systems · Siemens MES MCP · SAP S/4HANA · PI System · Cognex VisionPro · Siemens Teamcenter · Ansys · Figma · GitHub
Modules
Product Hierarchy
The system, subsystem, and component tree that risk analysis hangs from.
DFMEA Working Table
Severity, Occurrence, Detection, and RPN scored consistently across the team.
AI Failure-Mode Discovery
Candidate failure modes suggested from design context for an engineer to accept, refine, or reject.
Requirements Traceability
Requirements to functions to failure modes to verification tests, held as one chain.
Use cases
Medical Device Design Risk Analysis & ISO 14971 Compliance
A medical device company developing an automated wearable insulin infusion pump and continuous glucose monitoring (CGM) system seeking FDA 510(k) clearance and CE mark certification.
AI Assisted Failure Mode Discovery & Prevention Across Subsystems
A precision surgical robotics manufacturer developing a multi arm laparoscopic robotic surgery console with haptic feedback and stereoscopic visualization.
Thermal and Electrical Hazard Prioritization & Residual Risk Mitigation
An electro medical device manufacturer producing a high frequency electrosurgical generator and radiofrequency tissue ablation workstation.
End to End Requirements to Design Verification Test Traceability
A neurotechnology enterprise developing an implantable neurostimulator and wireless patient controller for chronic pain management.
Engineering Change Order Impact Analysis on DFMEA Risk Baselines
A commercial hemodialysis machine manufacturer managing a field fleet of 25,000 clinic dialysis consoles, implementing an engineering change to replace an obsolete blood flow sensor.
Audit Ready Digital Risk Documentation & Regulatory Submission Readiness
A multinational orthopedic implant and surgical instrumentation manufacturer facing an unannounced EU MDR notified body quality system audit.
Composable Architecture · Pairs well with
Accelerators that share systems of record, exchange real-time triggers, and compose with Tatvam.