ISO 14971 software for end-to-end risk control

Lumiform gives you access to over 12,000 templates in its library, and you can build or upload your own forms from PDFs, spreadsheets, or photos. If a validated ISO 13485 checklist exists in the library, you can start from it directly. You can also structure custom forms using the template builder to match specific ISO 13485 requirements, with AI assistance and prompting available. Once an inspection is completed, the platform automatically generates a report.

Access control is built into the platform. Roles and permissions determine what each user can see and do. Groups let you organize users into teams, so a quality manager and a floor operator do not share the same view or action rights. You assign forms, tasks, and actions to specific users or groups. Only the right people see the right data and receive the right tasks. This is configurable in the Administration section without requiring custom development work.

Lumiform operates as a cloud-based platform, accessible via desktop browser and mobile app from any location. Your team can run inspections, complete risk assessments, and review findings whether they’re on the production floor, in the office, or working remotely. All data syncs in real time across devices, so quality managers, auditors, and operators always work from the same current information. Cloud deployment eliminates the need for local server maintenance and ensures your team has immediate access to updated forms, assigned tasks, and compliance records without IT infrastructure overhead.

Lumiform includes AI features that support faster and more accurate risk-related workflows, particularly in form creation, data capture, validation, and analysis. AI can generate structured templates from prompts or existing documents, translate forms into multiple languages for global teams, validate photos against compliance standards in real time, and provide instant insights into trends or recurring issues without manual reporting. All throughout, your data remains safe, with all AI processing handled securely so your data is not stored after use or shared with third parties.

Lumiform supports the execution layer of ISO 14971 by turning risk controls into consistent, traceable work. You can run inspections and checks in a standardized way, capture evidence on the spot (for example photos, notes, and signatures), and generate reports immediately, so your risk control activities are documented and easy to verify. It’s also possible to assign corrective actions with clear owners and deadlines, so issues don’t stay open. The same records stay available across teams, which improves visibility for QA and management, so decisions are based on the latest field reality.

Lumiform provides a developer API and standardized integrations with tools including SharePoint, Google Drive, OneDrive, PostgreSQL, MySQL, MS SQL, Power BI, n8n, and Power Automate. These are one-click integrations, not custom builds. API access is available for connecting systems outside the existing integration list. Integrations are included in the Enterprise plan and available as add-ons on the Professional plan.

Yes, the mobile app is built for operational use: open a form, complete it, submit it. There is no complex navigation. Pending tasks appear on the home screen. Forms assigned to a user show up directly without that user needing to search or configure anything. The desktop handles administration, so frontline staff don’t have to touch the organizational layer. Many customers describe the platform as self-explanatory, with minimal training needed.