Audit-Ready Evidence for MDR, IVDR, and Beyond.
Laser AI accelerates critical evidence workflows with full traceability and uncompromised quality
Medical device companies depend on systematic literature reviews throughout their product lifecycle - from substantiating clinical claims and regulatory submissions to CER and SOTA reviews for MDR/IVDR compliance and post-market safety surveillance. These workflows are time-intensive, high-stakes, and growing faster than teams can scale manually.
Laser AI is built around your needs
Key Metrics
60% reduction demonstrated in cooperation with a global surgical robotics company
AI prioritization means fewer references need manual review to achieve 95% sensitivity
Up to 50% reduction in extraction time
SuperDeduper: 95% sensitivity, 100% specificity - zero lost references
Every decision time stamped; full history log per record - ready for Notified Body or FDA review
Full audit trail; PRISMA/Cochrane compliant; human-in-the-loop throughout
How Laser AI %supports% medical device companies
From Claims to CER: One Platform Across the Evidence Lifecycle
Whether substantiating product claims, preparing PSE reports, or producing CER and SOTA reviews for MDR/IVDR compliance, Laser AI supports the full evidence workflow in one platform - with AI prioritisation, dual screening, conflict resolution, and full traceability built in.
60% Less Time. Same Scientific Standard.
In a joint project with a global surgical robotics company, Laser AI reduced total analyst time on a PSE project by 60% while maintaining 95% screening sensitivity. Deduplication, AI-prioritized screening, and extraction each contributed measurable savings, replacing a fragmented multi-tool workflow with a single, reusable evidence repository.
Post-Market Surveillance at Scale
Continuously monitor global literature for adverse events and emerging safety signals without growing your team. Laser AI has been deployed in living systematic reviews processing over 15,000 references per month, keeping surveillance evidence current for PMCF and periodic safety reporting.
Enterprise Security for Sensitive Regulatory Data
ISO 27001, SOC 2 Type II, and FedRAMP certified - the only SLR platform with FedRAMP. Azure hosting in US or EU. Role-based access, flexible per-project permissions, and safe collaboration with external partners. Available for deployment on client infrastructure. Customer data is never used to train AI models.
Roadmap Note
Domain-specific extraction models for medical devices are on the Laser AI development roadmap.
TRUSTED BY LEADING MEDICAL DEVICE ORGANIZATIONS
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Flexible plans designed for teams and projects of every size.