Cyber Compliance & Quality | Xtint Technologies

CYBER COMPLIANCE & QUALITY

Xtint builds Cyber Secure hardware and software for tightly regulated industries

Medical, aerospace, automotive, space, and industrial automation don't forgive shortcuts. Xtint builds to the standards each of these industries is measured against, with the documentation and traceability audits require.

IEC 62304

ISO 13485

EU RED

CRA

DO-178C / DO-254

ISO 26262

IEC 61508

ECSS

FCC Part 15

UL / IEC 61010

RoHS / REACH

IEC 60601

Audit-ready QMS

Certified
product

Standards we build to

Compliance requirements vary by program and jurisdiction — we scope the applicable standard set with you at kickoff.

MEDICAL

IEC 62304

Medical device software lifecycle

MEDICAL

ISO 13485

Medical device quality management

EU · CONNECTED PRODUCTS

EU RED

Radio Equipment Directive — safety & security

EU · CONNECTED PRODUCTS

Cyber Resilience Act (CRA)

Cybersecurity requirements for connected products

AEROSPACE

DO-178C / DO-254

Airborne software & hardware assurance

AUTOMOTIVE

ISO 26262

Automotive functional safety

INDUSTRIAL

IEC 61508

Industrial functional safety

SPACE

ECSS Standards

European space product assurance

US / GLOBAL

FCC Part 15

US radio-frequency emissions & interference

SAFETY

UL / IEC 61010

Electrical equipment safety certification

ENVIRONMENTAL

RoHS / REACH

Restricted-substance compliance for global markets

MEDICAL

IEC 60601

Medical electrical equipment safety & performance

How we build for audit

Requirements traceability matrices

Static analysis and MISRA-style coding standards

Risk analysis, hazard, and FMEA documentation

Verification and validation test suites

Configuration and version control

Design history files and technical documentation

Secure-by-design: threat modeling, secure boot, encrypted storage, and hardened update paths from the first design review

Tell us your regulatory scope

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Xtint Technologies

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