Specializing in medical device
- Software Development
- Testing
- Remediation
- Cybersecurity
What We Do
Software engineering services exclusively for the medical device industry.
Software Development
Software Testing
Software Risk Management
Cybersecurity
Due Diligence
Artificial Intelligence (AI) & Machine Learning (ML)
Digital Health Technologies
Artificial Intelligence (AI) and Machine Learning (ML)
Why Should You Choose CriTech?
100%
Customer Submissions Approved by FDA/EU
Successful Customer Projects
30+
Years of Dedication & Expertise
- Exclusive focus on medical device software
- Flexible, custom solutions tailored for your needs
- Free project analysis
- Proven proprietary critical software development process
- Full-time engineers with years of medical device software experience
- Work performed without needing to be at your facility
- Excellent development environments with modern labs
- Collaborative Partnership: Consider us an extension of your team!
- ISO 13485-2016 Certification
Compliance with Medical Device Software Standards
We help 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.
Our Locations
Headquarters in Saline, Michigan, U.S.A. with an additional office in Costa Rica.
The CriTech Team
Our people are at the heart of what we do.
