Validate mechatronic medical devices against MDR & ISO norms — before you prototype. Upload M-CAD and E-CAD models for an early AI compliance and DFM evaluation across mechanical, electrical, and firmware disciplines. SafeProto is the compliance layer on your MBSE workflow, catching integration gaps and standard-clause mismatches early — so you avoid the cost, schedule, and rework of finding them after a prototype is built. Add prototype test data later for a closed-loop Final Evaluation and audit-ready documentation, in hours, not weeks.
Our Process
Design · AI Evaluate Design Model · Prototype · Test · AI Evaluate Test Result · Optimize — an endless cycle of excellence
From early design model evaluation to prototype test data analysis and regulatory submission — one platform, end-to-end.
Streamline both evaluation phases: upload 3D design models for early AI-driven design problem detection, and upload prototype test results for final validation against functionality, performance criteria, and ISO norms.
Evaluate material safety, cytotoxicity, sensitization, and systemic toxicity in compliance with ISO 10993 biocompatibility standards for medical devices.
Auto-generate FMEA reports, risk matrices, and design history files compliant with ISO 13485:2016 requirements.
Track critical-to-quality parameters and receive instant alerts when test results deviate from acceptance criteria.
Every submission is reviewed by certified compliance engineers before final approval — no algorithm alone decides.
Comprehensive, structured reports with traceability matrices and corrective action plans ready for notified body audits.
Join medical device companies already using SafeProto to accelerate their regulatory pathway — from biocompatibility to full ISO 13485 certification.
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