Prepare source-linked proposals across design, manufacturing, complaints, CAPA, and post-market evidence without bypassing the risk-management process. Qualified Product, Quality, Clinical, and Regulatory owners decide what enters the controlled file.
Use approved design inputs, specifications, prior analyses, and verification evidence to propose DFMEA content and identify missing links. FMEA supports the ISO 14971 process; it does not replace hazard identification, risk evaluation, risk-control decisions, benefit-risk analysis, or overall residual-risk evaluation.
Prepare PFMEA and control-plan proposals from process flows, specifications, and qualification or validation evidence. Manufacturing and Quality reviewers confirm links to product risk controls and approve any controlled revision.
Compare complaints, nonconformities, service records, vigilance inputs, and other post-market evidence with the approved risk baseline. Tacit AI flags possible new hazards, hazardous situations, or changed occurrence assumptions for qualified assessment.
Show where proposed corrective actions or design and process changes may affect risk controls, verification evidence, and existing analyses. CAPA effectiveness and change approval remain in the manufacturer’s quality system.
Keep sources, assumptions, reviewer decisions, versions, and exceptions visible. Deployment, access, validation, electronic-record controls, and integration are defined with the customer’s Quality, Regulatory, and IT owners.
Inventory identifiers, versions, lifecycle links, and missing context before preparing risk proposals. Qualified teams can resolve source gaps before relying on the output.
The pilot baseline and success criteria are agreed in advance. Results are reported only for the selected device scope, evidence set, method, and named review group.
Qualified product, quality, clinical, and regulatory teams assess the evidence, determine device acceptability, and own the manufacturer’s QMSR, ISO 13485, ISO 14971, and regulatory responsibilities.
For Quality, Regulatory, R&D, Manufacturing, Post-Market, and Product Safety leaders working within the effective FDA QMSR, ISO 13485:2016, ISO 14971, or EU MDR frameworks.
Start with a defined subsystem or risk question. Tacit AI proposes linked analysis content; qualified owners review it against the manufacturer’s risk-management plan and acceptance criteria.
Use selected complaints, CAPAs, service records, and post-market outputs to identify where the approved risk baseline may warrant reassessment. The manufacturer controls investigation and revision.
Support is workflow-specific and does not confer conformity, certification, or regulatory acceptance.
Your team defines the intended use, authoritative sources, reviewers, controlled-system boundary, baseline, and success criteria before Tacit AI prepares any proposals.
Customer-defined
Choose a device, subsystem, lifecycle stage, evidence set, and qualified reviewers. Record exclusions and the status of pilot outputs.
Deliverable
Approved scope, baseline, evidence inventory, and review rubric.
Agreed schedule
Tacit AI prepares proposed additions, links, and possible gaps. Reviewers accept, revise, or reject them and record why.
Decision
Continue only if agreed traceability, coverage, and review-effort criteria are met.
After validation
Approved outputs follow the manufacturer’s document, design-change, CAPA, validation, and release procedures. Additional families require their own applicability review.
Decision
Expand against customer-defined quality and lifecycle outcomes.
Bring the approved risk analysis and a bounded set of design, manufacturing, complaint, or CAPA evidence. We will define the traceability and review criteria together.
