Modulux Systems delivers cutting-edge medical device engineering, regulatory compliance management, and full-stack systems integration for healthcare providers worldwide.
Every module is engineered to meet the rigorous demands of modern healthcare environments — from regulatory compliance to real-time system monitoring.
Built-in regulatory frameworks for FDA 21 CFR Part 820, ISO 13485, and CE marking requirements.
Live telemetry and alerting across all connected medical devices, 24/7 with zero downtime SLA.
End-to-end encryption and HIPAA-compliant data pipelines for patient data protection at every layer.
Plug-and-play modules that integrate with existing hospital EHR systems and infrastructure.
Dedicated biomedical engineers and compliance specialists available around the clock.
Comprehensive dashboards and automated reporting for clinical performance and equipment utilization.
From concept to compliance, we deliver full-spectrum engineering services tailored to healthcare innovators.
Hardware and firmware development for Class I, II, and III medical devices. We manage full design history files (DHF) and device master records (DMR) throughout the product lifecycle.
510(k) submissions, PMA applications, CE Technical Documentation, and ISO 13485 quality management system implementation and auditing.
Seamless HL7 FHIR and DICOM integration with Epic, Cerner, and Allscripts EHR systems. Real-time data exchange across clinical environments.
IEC 62304 compliant software development for medical device software (MDSW), including AI/ML-enabled clinical decision support tools.
Verification and validation (V&V) testing, usability engineering studies (IEC 62366), and risk management per ISO 14971.
Ongoing complaint handling, MDR/MAUDE reporting, and post-market clinical follow-up (PMCF) programs to maintain market authorization.
Founded by biomedical engineers and regulatory experts, Modulux Systems was built on a single principle: that life-critical technology demands absolute precision. Over 15 years, we've helped 200+ healthcare organizations bring safer, smarter medical innovations to market.
Our multidisciplinary team spans regulatory affairs, embedded systems, clinical software, and quality management — giving clients a single trusted partner from concept through post-market surveillance.
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Modulux's regulatory team helped us clear FDA 510(k) in record time. Their deep knowledge of the submission process and proactive communication saved us months of back-and-forth.
Their systems integration team connected our legacy PACS with our new EHR flawlessly. The DICOM-FHIR bridge they built has been running without incident for over 18 months.
From IEC 62304 software documentation to usability studies, Modulux handled the entire compliance workstream. Our CE mark was achieved on the first submission.
Whether you're launching a new medical device or navigating a complex regulatory challenge, our team is ready to help. Reach out for a no-obligation consultation.
