AI Risk Management Module
Manage safety, cybersecurity, and process risks in one integrated module tightly connected with all your product documentation. Replace complex spreadsheets with a customizable, structured, audit-ready solution — enhanced by AI.
What are the benefits?
Reduce team load
Reduce manual effort by up to 70% compared to Excel-based risk registers.
Raise the quality bar for risk process by fostering the team collaboration within live discussions in the comments.
Cut time & Boost traceability
Cut review cycle time in half with one-click AI risk review & update.
Achieve 100% traceability — every risk linked to controls, mitigations, and residual acceptance.
Setup continuos process
Stay continuously compliant with ISO, FDA, and MDR expectations by using regular checkup tasks to review and update the risks.
Break the silos and stay connected with the rest of the product documentation bi-directionally.
Why choose the ins2outs Risk Management module?
One module, all risk types
Capture and manage safety, cybersecurity, and process risks in a single, standardized workspace — aligned with ISO 14971, ISO 13485, and ISMS requirements.
AI-powered efficiency
Generate risks from simple prompts, and your documentation context, run automated reviews against the latest standards and threat databases (coming soon), and keep your register always up to date.
Traceability you can trust
Link risks directly to SOPs, product documentation, or audit findings. Every change is logged for complete regulatory compliance. Access any version at any time.
Simple collaboration
Assign tasks, mention team members in comments, track status, and keep teams aligned across engineering, regulatory, IT, and quality management.
Audit-ready by design
Preconfigured templates for each risk type and reports mean you’re always prepared for inspections, certifications, and client audits.
Pricing
Risk Management Module
- Converts days of work into several clicks
- Seamlessly integrated in ins2outs starting from Premium subscription plan
- Can be purchased as a separate module
- Suitable for any organization thanks to custom workflows per risk type
ins2outs Premium
- Cloud-hosted
- Volume discounts starting from 100 active users
- Premium features package including integrations
- Full view and edit rights
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