Build products. Not paper trails.
Integrate compliance directly into product development without slowing innovation, and preserve IP as it's created. Design & Development, ISO 14971 risk, V&V, and a living DDF, connected to the CAPAs, complaints, and changes that inform the design across its lifecycle.
The DDF as a working document not a final binder.
Design & Development and risk live in the same platform as the CAPAs, complaints, and changes that inform them. Traceability is a property of the records, not a manual matrix.
Design & Development, configurable
Inputs, outputs, reviews, verifications, validations, transfer. Flow them per project type without bending the system.
Risk file, alive
ISO 14971 risk file lives next to the design. Hazards link to mitigations, V&V, complaints, and CAPAs: all bidirectionally.
Traceability matrix, built-in
Requirements → outputs → verifications → validations. Drill into evidence; no manual matrix to maintain.
Change-aware
A change request automatically flags requirements that need re-V&V and hazards that need re-evaluation.
Auto-snapshot DDF
Every gate captures a snapshot of the DDF state, submissions and audits draw from a known point in time.
LuminLogic IQ embedded
Summarize requirement deltas, draft V&V rationale, flag missed traces, citations log to the audit trail.
Development project planning
Coordinate development milestones, requirements, risks, design reviews, verification, validation, evidence, and submission readiness throughout the product lifecycle.
A design, end to end.
Out-of-the-box for 21 CFR Part 820, ISO 13485 §7.3, and ISO 14971: admin-configurable per project class.
Plan
Define inputs, outputs, and gates per project type. Reusable blueprints standardize across product lines.
Design
Capture inputs, outputs, reviews, and risk in-platform. Linked records assemble traceability automatically.
Verify & validate
IQ-assisted V&V planning. Protocols and reports linked to requirements and hazards directly.
Transfer & maintain
Transfer to manufacturing under signature. Lifecycle changes update the DDF automatically.
Engineering & DDF lives on the same platform as everything else.
Submissions
Tech files and 510(k) assemble from your DDF, no parallel binder.
Learn moreChange Control
Design changes carry impact directly into V&V, risk, and submissions.
Learn moreCAPA
CAPA findings link to hazards and requirements they touch.
Learn moreSupplier Quality
Component changes flow back to DDF as inputs.
Learn moreInputs to V&V, one living thread.
Requirements, design outputs, verification, validation, and risk: linked end to end, with IQ flagging the gaps before an auditor does.
Risk and design & development, always in sync.
Hazards, mitigations, and residual risk live alongside the requirements and verifications they govern. Change a design output and the linked risk and V&V flag for review, no parallel ISO 14971 spreadsheet.
Hazard → mitigation → residual, traced.
Design edits flag linked risk & V&V.
Bring your DDF into the same world as your CAPAs.
See how design controls, risk, and V&V connect to lifecycle quality, without duplicate sources of truth.