What We Do

Development and Testing of Safety-Critical Software Exclusively for the Medical Device Industry.

Our Services

Development and Testing of Safety-Critical Software Exclusively for the Medical Device Industry

Software Development

Full SDLC engagement following critical software development process from requirements to validation with complete requirements traceability

Software Testing

Independent IEEE compliant V&V and Intended-Use Validation from test plan development to test execution and reporting

Software Risk Management

Risk analysis including hazards list and associated risk control measures aligned with ISO 14971 risk management processes

Remediation

Identify and remediate gaps in software DHFs and TFs with complete requirements traceability

Cybersecurity

Threat modeling and risk analysis through penetration tests and vulnerability assessments, completed with reports on recommended controls and mitigation practices

Due Dilligence

Software regulatory compliance screening during corporate acquisitions and licensing engagements including design history file review

Artificial Intelligence (AI) and Machine Learning (ML)

Incorporating predictive analysis and data management into medical software while ensuring regulatory compliance

Digital Health Technologies

Cross-platform MMA development and testing using Swift and Objective-C in Xcode and Kotlin and Java in Android Studio

We Look Forward to Talking with You

We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!

Saline, Michigan

1705 Woodland Drive East, Suite 100
Saline, MI 48176

San Jose, Costa Rica

CC El Obelisco Local #14
San Rafael of Escazu
San Jose, Costa Rica

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