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, Software
Verification and Validation, and Sotware Safety Engineering. Our
wealth of experience allows us to provide custom solutions tailored
to meet your needs.
CriTech is ISO-9001:2008 certified for software development. We
were one of the first software companies in North
to receive this certification.
FDA and European Union Regulatory Compliance
At CriTech, we
follow an IEEE based Critical Software Development Process (CSP),
which is a fundamental part of our quality system. Our quality
system is compliant with the FDA Quality System Regulation, which
supports 510(k) and PMA submissions, and satisfies the software-related
requirements of major medical device standards, including:
- EU Medical
Device Directive (93/42/EEC)
- ISO 13485:2003,
Medical devices – Quality management systems – Requirements for
- ISO 14971:12207,
Medical devices – risk management
- IEC 62304:2006,
Medical device software -- software life cycle processes
- Good Automated
Manufacturing Practices (GAMP)
We have over 50 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 (7, Vista, XP, CE/Mobile, Legacy),
UNIX (Linux, QNX, Solaris), PLC Systems, and Communications.
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.
experience in the development of medical manufacturing applications
includes line control, incoming and manufacturing acceptance test,
CriTech Research Services
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.
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.