Search for:

CriTech Research develops software for Food and Drug Administration (FDA) regulated industries. We provide our customers with a variety of services, including Systems Engineering, Software Engineering, Consulting, and Technical Training. Our wealth of experience allows us to provide custom solutions tailored to meet your needs. ISO-9001 CriTech is ISO-9001:2000 certified for software development. We were one of the first software companies in North America to receive this certification. FDA and European Union Regulatory Compliance At CriTech, we follow an IEEE compliant Critical Software Development Process (CSP), which is a fundamental part of our quality system.  Our quality system is compliant with the FDA’s Quality System Regulation, which supports FDA 510(K) and PMA submissions as well as subsequent audits.  In addition, our quality system is fully compliant with various applicable standards, including the Medical Device Directive (93/42/EEC), IEC 60601-1-4 “Safety Standard for Programmable Electrical Medical Devices,” GAMP, and AAMI SW-68.  Our compliance with these European standards and regulations supports the CE Marking process. Staff We have over 30 software engineers with a wide range of software expertise that can be brought to bear on a microcontroller/processor- or a workstation-based application.  Our specialties include Real-time, GUI, Database Design (Oracle, SQL, MS Access), Architecture, Imaging, Safety Engineering, Requirements Analysis, Design, Test, Embedded Microcontrollers, Windows (3.1, 95, 98, 2000, NT, CE, XP), UNIX (Linux, QNX, Solaris, SGI, AIX), PLC Systems, and Communications. Experience Our expertise has been applied to a wide variety of medical applications, including Ambulatory Infusion Pumps, Arthrombic Pumps, Artificial Heart, Dialysis Systems, Neonatal Incubators, Hospital Patient Monitors, Stereotactic Radiosurgical / Radiotherapeutic Systems, Enteral Nutrition Pumps, Nuclear Medicine Imaging, Gamma Cameras, Blood Chemistry Analyzers, Pain Management, Cardiac Assist, Wireless EEG, Slide Stainer Management, Blood Counters,  Hospital Beds, Mammography Systems, Tissue Oximeters, and Stem Cell Growth Systems. Our experience in the development of medical manufacturing applications includes line control, incoming and manufacturing acceptance test, and sterilization. CriTech Research Services
	Independent Verification and Validation Services CriTech provides a variety of software testing services, from development of test plans, test designs, test cases, and test procedures through actual test execution and reporting. We offer complete Independent Verification and Validation of the software in a customer's product. We follow an IEEE compliant Verification and Validation process that results in documentation that aids technology transfer to the customer at the end of the project.
	Software Engineering Outsourcing CriTech will take a high-level set of system or software requirements for a product from a company and perform all software development activities required to produce safe, reliable software. At every phase of the project, our Critical Software Development Process (CSP) provides detailed guidance for Project Management, Quality Assurance, Configuration Management, Engineering, Safety Engineering, and Verification and Validation activities. During development, our Project Management Plans and periodic status reports provide visibility into each of the activities required for successful software development.
	Safety Engineering We utilize both Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA) to discover and evaluate system and software safety faults.
	Communications Development We provide communications solutions using many protocols including Hospital Information Systems (HL7), Laboratory Information Systems (LIS), Controller Area Network (CAN), Ethernet, Bluetooth, DeviceNet, IDB, ARINC, MIL-STD-1553B, and proprietary networks.
	Requirements Traceability We have experienced software engineers familiar with providing traceability for software and systems.  We provide traceability analysis of legacy systems which will identify any problems with the documentation.  We also provide solutions for problems we may encounter.
	21 CFR Part 11 CriTech provides consulting services to assist medical device and pharmaceutical companies to meet the requirements for fully compliant systems.  Our services result in your systems providing detailed audit trail, security, and electronic signature features as required by 21 CFR Part 11  We develop comprehensive SOPs and policies to prevent record falsification.  We ensure that your systems are validated and help you maintain them in a validated state.

Send email to: websupport@critech.com with questions or comments about this web site. Copyright © 1999-2006 CriTech Research Last modified: May 2006