What We Do

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

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Development

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

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Testing

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

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Software Risk Management

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

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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

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Due Diligence

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

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Artificial Intelligence (AI) and Machine Learning (ML)

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

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Digital Health Technologies

CriTech develops and tests Digital Health Technologies (DHT) in compliance with regulatory standards and industry best practices. Our expertise spans digital medicine, digital therapeutics, and Software as a Medical Device (SaMD), enabling safe and effective healthcare solutions.

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!