CriTech helps medical device manufacturers ensure their software is fully compliant with major medical device standards. We work exclusively for the medical device industry and have been in business for over 30 years.
CriTech specializes in Medical Device Software Development, Testing, Remediation, Risk Management, Artificial Intelligence (AI) & Machine Learning (ML), and Cybersecurity.
• ISO 13485:2016 Certification
• Focus exclusively on medical device software
• 100% first-time approval rate for our work products used in submissions with both the FDA and EU
• Offer free project analysis
• Solutions for all FDA device classes and IEC 62304 software safety classifications
• Flexible, custom-tailored solutions set to meet your specific needs for safety-critical software
• Specialized expertise in communications and User Interface (UI) development
• Experience in designing databases to support both dedicated applications and cloud-based servers
• Consulting for medtech firms to include due diligence, software documentation, and other services
Our staff has diverse backgrounds in microcontrollers, PC- based systems, web-based systems, mobile medical applications, and Software as a Medical Device (SaMD).
CriTech has been improving product quality and patient safety, one medical device at a time, for over 30 years.
Company Details
- Employees
- 36
- Founded
- -
- Address
- 1705 Woodland Dr E, Saline,michigan 48176,united States
- Phone
- 734-668-0005
- Industry
- Software Development
- NAICS
-
Software Publishers
- Website
- critech.com
- Keywords
- Software Development for Medical Devices, Cybersecurity for Medical Devices, ISO 13485:2016 Certified, Artificial Intelligence (AI) & Machine Learning (ML) for Medical Devices, Ensure compliant software for medical devices, Software Verification & Validation for Medical Devices, MedTech Consulting, User Interface Development for Medical Devices, Medical Device Software Documentation, Medical Device Software Testing, Medical Device Software Engineering Services, Due Diligence for MedTech Companies, Software Remediation for Medical Devices, Intended Use Validation for Medial Devices, IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security, Software as a Medical Device (SaMD), Implantables, Digital Health Technologies, Wearable Devices.
- HQ
- Saline, Michigan
Critech Research, Inc. Questions
Critech Research, Inc.'s helpline number is 734-668-0005
Critech Research, Inc.'s website is critech.com
Critech Research, Inc.'s LinkedIn profile is https://www.linkedin.com/company/critech-research-inc
Critech Research, Inc. has
36 employees.
View email and phone details for 36
employees at Critech Research, Inc..
Critech Research, Inc.'s industry is
Software Development
Critech Research, Inc.'s top competitors are
Md Live By Evernorth,
Hyman, Phelps & Mcnamara, P.c.,
Infinite Computer Solutions,
Mem0,
Courier Health,
Parasoft,
Power Design, Inc.,
Lg Nova,
Vectra Ai,
Genome Medical.
Critech Research, Inc.'s categories are Software Development
Critech Research, Inc.'s founding year is 1994
