Quality & Risk Management Software· Clarit
One platform for the entire product development lifecycle.
From user needs to submission-ready.
Clarit is an AI-driven design, risk, and quality environment — connecting every stage of product development in a single traceable system, with regulatory guardrails built in from the first requirement.
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ISO 13485 · ISO 14971 · 21 CFR 820 · IEC 62304 · and more
The full product development lifecycle — in one place.
Every stage of regulated product development — from defining what the product needs to do, through design, risk, verification, validation, and document control — requires rigorous compliance management. Clarit structures that entire process so nothing is undocumented, nothing is untraced, and nothing is missing when you reach submission.
User Needs & Design Inputs
Start where development actually starts.
Define user needs in collaboration with marketing and clinical stakeholders. Translate them into formal design inputs (product requirements). Clarit structures this foundation so every downstream design decision can be traced back to a documented user need — the requirement that drives everything else.
Design Outputs & Integrations
Connected to the tools your team already uses.
Design outputs — drawings, specifications, code — integrated with Solid Edge and other 3D modeling tools for hardware development. For SaMD, integrations with leading code generation tools and GitHub keep software development connected to the compliance record. Project tracking integrates with Jira so regulatory milestones stay aligned with development timelines.
Verification & Validation
Requirements to test cases — bidirectional traceability.
Develop verification requirements from design inputs and risk controls. Develop validation protocols with customer involvement. Every test case traced to the requirement it validates — no orphaned test cases, no untested requirements, and no surprises when the submission reviewer checks your traceability matrix.
Risk Analysis & Control
ISO 14971 compliance built into the development process.
Detailed risk analysis connected to your design history and updated continuously as requirements evolve through Synthesis. Risk controls mapped to design outputs and verification activities. Standards compliance across ISO 14971, IEC 62366, IEC 60601, IEC 62304, ISO 13485, and ISO 19011.
Document Control & Training
Version control, change history, and stakeholder training.
Every document version-controlled with full change history. SOPs and templates ready to use from day one. Training delivery to key stakeholders built in — so your quality system isn't just documented, it's operational.
Labeling & Submission Handoff
Clarit feeds Composit and Folio.
Label requirements and design output documentation generated in Clarit feed directly into Composit for multi-market label production. Design history files and technical documentation assembled in Clarit feed Folio for submission preparation. One integrated workflow from development through filing.
Why teams choose Clarit.
One platform
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Regulatory, design, quality, risk, labeling, and submissions — connected in a single environment instead of scattered across tools that don't talk to each other.
AI with regulatory guardrails
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AI-driven analysis and generation — but within the compliance boundaries that regulated product development demands. Speed without shortcuts.
Full traceability
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Every design decision traceable from user need through test result. Every compliance obligation mapped. No gaps when the submission reviewer checks your DHF.
Standards compliance
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ISO 13485 · ISO 14971 · IEC 62304 · IEC 62366 · IEC 60601 · ISO 19011 — built in, not bolted on.
Ready-to-use SOPs & templates
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Pre-built compliance documentation so your team isn't starting from scratch — and the library stays current as standards evolve.
Integrations that work
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Jira, GitHub, Solid Edge, eQMS platforms — Clarit connects to the tools your team already depends on.