Improving product quality and patient safety, one medical device at a time.

Specializing in Medical Device Software Development, Testing, Remediation, and Cybersecurity

Diverse Group of Professionals Meeting in Modern Office: Brainstorming IT Programmers Use Computer Together, Talk Strategy, Discuss Planning. Software Engineers Develop Inspirational App Program

What We Do

Specialize in Medical Device Software Development, Testing, Remediation, Artificial Intelligence (AI) & Machine Learning (ML), and Cybersecurity.

More About Our Services

Medical Device Software Regulatory Compliance

CriTech Research helps medical device manufacturers ensure their software is fully compliant with major medical device standards and rigorously tested through our software engineering solutions.

We provide custom-tailored solutions set to meet your specific needs for safety-critical software with products from all FDA device classes and IEC 62304 software safety classifications.

We also provide consulting for medtech firms to include due diligence, software documentation, and other services.

More About Our Compliance

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Why Choose CriTech?

100%

Customer Submissions Approved by FDA/EU

30+

Years of Expertise

500+

Successful Customer Projects

Focus exclusively on medical device software

Proven proprietary Critical Software Development Process

Offer free project analysis

Full-time CriTech engineers with years of medical device software experience

Work performed without needing to be at your facility

Excellent development environments with modern labs

Flexible, custom solutions tailored to meet your needs

Collaborative Partnership: Consider us an extension of your team!

ISO 13485:2016 Certification

Learn More About What We Offer

More About Our Experience

Customer Testimonials

“Thank you for coming to our aid and helping us get the firmware documentation under control, restructuring/improving the firmware, and validating the firmware. The FDA raised no issues with the software package you provided us. Your team was highly engaged and accountable. You are a first-rate partner.”

Vice President

Quality

“Today we received 510(k) clearance from the FDA in relation to our new product. Your contributions played a key role in receiving the FDA’s blessing. On behalf of our entire company – thank you very much for your outstanding support!”

CEO

Company

“CriTech did a fantastic job on the project we outsourced to them! Budgetary and timeline targets were met – a rare engineering accomplishment. Communications throughout the project were excellent. The process worked just as it is supposed to. CriTech performed for us!”

Vice President, Research & Development

Company

“It’s always great to work with CriTech! You’re easy to do business with and your work is superior. Budgets and timelines have always been met.”

Medical Device Software Manager

Company