The intelligent compliance & manufacturability platform for medical device engineers. Upload Design Model data for an early AI evaluation of your hardware & software design — identifying compliance gaps, MDR regulatory issues, and Design for Manufacturing (DFM) risks before a single prototype is built. Upload prototype test data for Final Evaluation against functionality, performance criteria, and ISO norms. Trigger AI-driven ISO analysis and receive audit-ready documentation and actionable manufacturability feedback — including a Preliminary Cost Intelligence estimate for raw materials, workshop machining, and duties across global manufacturing tiers — 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.
An air-gapped edge gateway that retrofits onto deployed clinical devices — monitoring compliance and analysing patient-generated clinical data locally, inside the clinic. Patient data never leaves the hospital network.
SafeProto Edge Gateway
NVIDIA Jetson Orin NX · Air-Gapped
Live CAN bus / serial evaluation against validated Phase 1 safety baseline. Auto-generates MDR Article 83 PMCF deviation reports. Manufacturer's post-market obligation satisfied automatically.
Ingests device-generated clinical data — DICOM images, waveforms, sensor logs — and runs local AI inference to produce structured clinical reports for hospital staff. Zero data egress.
100% air-gapped · No cloud · No data egress · Patient data stays in the clinic
GDPR Article 9, IEC 62443, and hospital procurement policies block cloud-native clinical AI before clinical evaluation even begins. Our local-only architecture eliminates the data processing agreement, the patient consent workflow, and the GDPR friction entirely — converting the hardest procurement objection into a closed objection.
For a radiology device, the gateway intercepts a read-only DICOM copy, runs a local vision model, and generates a pre-structured report — measurements, anomaly flags, differential considerations — before the radiologist opens their worklist. The clinician reviews and signs. Turnaround collapses. Not a single pixel leaves the hospital.
The manufacturer pays €8K–€15K per unit + €3K–€6K/year for automated PMCF compliance. The hospital department pays €18K–€40K/year for clinical intelligence. One hardware unit. Two contracts. Two buyers. Neither cannibalises the other.
Join medical device companies already using SafeProto to accelerate their regulatory pathway — from biocompatibility to full ISO 13485 certification.
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