Business Details
32 Years
experience
Medical Device Software Development Services
Critech Research has been dedicated to medical device software engineering excellence for over 30 years. Our ISO 13485:2016-certified process ensures compliance with FDA, EU, IEEE, and IEC standards through our proprietary Critical Software Development Process. We specialize in full SDLC engagement for safety-critical software, delivering independent verification and validation services that have supported hundreds of successful FDA and EU approvals.Our team of experts provides regulatory compliance consulting, cybersecurity risk analysis, and remediation services tailored to medical device manufacturers. With headquarters in Saline, Michigan, and an additional office in Costa Rica, we offer flexible solutions that integrate seamlessly with client operations while maintaining rigorous quality standards.
Services
Software Development
Software Testing
Risk Management
Cybersecurity
AI/ML Integration
Digital Health
Remediation Services
Due Diligence
Details
- Year established: 1994
Highlights and features
- 30+ years of medical device software expertise
- ISO 13485:2016 certified quality management system
- 100% customer submissions approved by FDA/EU
- Proprietary IEC 62304 compliant development process
- Full-time engineers with specialized medical device experience
Associations and certifications
- ISO 13485:2016
What people say
First-rate partner
Outstanding support
Superior work
Excellent communication
Proven process
Services
Software Development
Full software development lifecycle management from requirements to validation. Our IEC 62304-compliant process ensures complete traceability and FDA/EU approval readiness. Services include requirements engineering, architecture design, coding, and verification testing for safety-critical medical device software.
Software Testing
Independent verification and validation services covering test planning, execution, and reporting. We ensure compliance with FDA quality system regulations through comprehensive testing protocols that validate software functionality and safety requirements.
Risk Management
Comprehensive risk management services aligned with ISO 14971 standards. Our process includes hazard identification, risk analysis, and implementation of control measures to ensure patient safety while maximizing ROI for medical device manufacturers.
Cybersecurity
Medical device cybersecurity services including threat modeling, penetration testing, and vulnerability assessments. We implement secure development practices that meet FDA cybersecurity guidance and protect against evolving digital threats.
AI/ML Integration
Implementation of artificial intelligence and machine learning technologies in medical software. Our approach ensures regulatory compliance while leveraging predictive analytics to improve diagnostic accuracy and treatment outcomes through validated algorithms.
People
Bob Rajewski
Founder and President
Recognized medical device software expert with 30+ years experience. Former FDA/AAMI instructor. US Air Force veteran. Holds BS degrees in Computer Science and Electrical Engineering from Michigan Tech.
Royene Moore
Director of Sales
Medical technology sales leader with 20+ years experience. Former executive at IBM and Computer Associates. Holds BS in Math and Chemistry from University of New Mexico.
Randy Smith
VP Sales and Marketing
Veteran sales executive with embedded systems expertise. US Marine Corps officer. Holds BS in Aerospace Engineering from US Naval Academy and MA in Management from Webster University.
Questions
What medical device software services do you offer?
We provide full SDLC development, testing, risk management, cybersecurity, AI/ML integration, and regulatory compliance services for medical devices.
How do you ensure regulatory compliance?
Our ISO 13485:2016-certified process follows FDA, EU, IEEE, and IEC standards with complete requirements traceability.
Do you handle all device classifications?
Yes, we support all FDA device classes (I, II, III) and IEC 62304 software safety classifications (A, B, C).
Can you help with documentation remediation?
Our team specializes in bringing DHFs and technical files into compliance with complete traceability.
Where are your facilities located?
We have headquarters in Saline, Michigan, and a fully equipped office in San José, Costa Rica.
