CriTech Research
CriTech Research specializes in medical device software development, testing, remediation, cybersecurity, and compliance. They focus on helping medical device manufacturers meet regulatory standards such as FDA, EU, ISO 13485, IEC 62304, and ISO 14971. With over 30 years of experience, CriTech aims to ensure first-time regulatory approval, complete requirements traceability, and high-quality software development. They also offer remediation services for compliance issues and have a strategic alliance with The Realtime Group to streamline medical device development. CriTech is committed to improving product quality and patient safety through innovative and compliant software solutions.
Industries
Nr. of Employees
small (1-50)
CriTech Research
Products
medical software
CriTech Research provides services for integrating Artificial Intelligence (AI) and Machine Learning (ML) technologies into medical device software, including development, improvement, data management, and regulatory compliance.
Medical Device Software Development Services
Professional software development services for medical devices, utilizing an IEC 62304 compliant, IEEE-based Critical Software Development Process designed to meet FDA and EU requirements.
Independent Software Verification Services
Independent IEEE-compliant verification services including development of plans, designs, test cases, procedures, test execution, and reporting.
Software Remediation Services
Identify and remediate gaps in software Design History Files and Technical Files with complete requirements traceability and reverse engineering.
Medical Device Compliance QA
Quality assurance and compliance consulting services for medical device software ensuring adherence to FDA, EU, and ISO standards.
Software Testing
Independent IEEE compliant V&V and Intended-Use Validation from test plan development to test execution and reporting.
medical software
CriTech Research provides services for integrating Artificial Intelligence (AI) and Machine Learning (ML) technologies into medical device software, including development, improvement, data management, and regulatory compliance.
Medical Device Software Development Services
Professional software development services for medical devices, utilizing an IEC 62304 compliant, IEEE-based Critical Software Development Process designed to meet FDA and EU requirements.
Independent Software Verification Services
Independent IEEE-compliant verification services including development of plans, designs, test cases, procedures, test execution, and reporting.
Software Remediation Services
Identify and remediate gaps in software Design History Files and Technical Files with complete requirements traceability and reverse engineering.
Medical Device Compliance QA
Quality assurance and compliance consulting services for medical device software ensuring adherence to FDA, EU, and ISO standards.
Software Testing
Independent IEEE compliant V&V and Intended-Use Validation from test plan development to test execution and reporting.
Services
End-to-end development of medical device software and embedded firmware, including requirements, design, implementation and validation in compliance with medical device standards.
Independent verification and validation services across unit, integration and system levels, including manual and automated testing, regression testing, and producing auditable test evidence.
Risk analysis and mitigation services for software hazards aligned with ISO 14971 and IEC 62304, including identification of risk controls and documentation.
Services to identify gaps, reconstruct or update DHFs/Technical Files, perform reverse engineering of requirements, and prepare documentation for regulatory compliance.
Cybersecurity risk assessments, penetration testing, vulnerability assessments, SBOM support and documentation of cybersecurity controls for regulatory submissions.
Technical assessments of software compliance for acquisitions, licensing, or investment, including evaluation of documentation, testing and regulatory readiness.
End-to-end development of medical device software and embedded firmware, including requirements, design, implementation and validation in compliance with medical device standards.
Independent verification and validation services across unit, integration and system levels, including manual and automated testing, regression testing, and producing auditable test evidence.
Risk analysis and mitigation services for software hazards aligned with ISO 14971 and IEC 62304, including identification of risk controls and documentation.
Services to identify gaps, reconstruct or update DHFs/Technical Files, perform reverse engineering of requirements, and prepare documentation for regulatory compliance.
Cybersecurity risk assessments, penetration testing, vulnerability assessments, SBOM support and documentation of cybersecurity controls for regulatory submissions.
Technical assessments of software compliance for acquisitions, licensing, or investment, including evaluation of documentation, testing and regulatory readiness.
Expertise Areas
- Medical device software development
- Software verification & validation (IV&V)
- Regulatory compliance and submission support (FDA, EU)
- Cybersecurity for medical devices
Key Technologies
- Embedded firmware development
- Mobile application development (iOS, Android)
- Automated static code analysis
- Unit testing and code coverage
News & Updates
Collaboration delivers automated testing solutions for embedded and safety-critical applications, supporting modern static analysis, unit testing, and code coverage.
Introduction to CriTech as partners in innovation and compliance, led by founder and president Bob Rajewski.
Principles for developing high-quality medical device software, emphasizing standards, early QA, testing focus, and team involvement.
Exploration of how CriTech ensures medical device software meets and exceeds regulatory standards.
Partnership to streamline medical device development, offering hardware, design, prototyping, and engineering solutions.
Discussion on FDA requirements for cybersecurity in medical devices.
Collaboration delivers automated testing solutions for embedded and safety-critical applications, supporting modern static analysis, unit testing, and code coverage.
Introduction to CriTech as partners in innovation and compliance, led by founder and president Bob Rajewski.
Principles for developing high-quality medical device software, emphasizing standards, early QA, testing focus, and team involvement.
Exploration of how CriTech ensures medical device software meets and exceeds regulatory standards.
Partnership to streamline medical device development, offering hardware, design, prototyping, and engineering solutions.
Discussion on FDA requirements for cybersecurity in medical devices.