Product Experience
Development and Testing of Safety-Critical Software Exclusively for the Medical Device Industry
What Sets Us Apart
CriTech Research has an exceptional track record of testing and developing medical device software for a wide range of applications. We have worked on over 500 projects and have achieved a 100% first-time approval rate for our work products used in submissions with both the FDA and EU.
Our staff has diverse backgrounds in microcontrollers, PC-based systems, web-based systems, mobile medical applications, and Software as a Medical Device (SaMD).
We have specialized expertise in communications and User Interface (UI) development. In addition, we have experience in designing databases to support both dedicated applications and cloud-based servers.
Some of our past medical device software projects are listed below.
| Ambulatory Infusion Pumps | Enteral Nutrition Pumps | Neonatal Incubators |
| Arthrombic Pumps | External Heart Defibrillator System | Neurostimulator - embedded software and programmer |
| Artificial Heart | Flat Panel X-Ray Systems | Nuclear Medicine Imaging |
| Bioimpedance Instruments for Lymphedema | Gamma Cameras | Optical Biopsy System |
| Blood Cell Counters | Glucose Meters & Patient Software (PC and Web) | Optical Coherence Tomography |
| Blood Chemistry Analyzers | Hearing Systems | Pain Management |
| Blood Parameter Monitoring Systems | HIV Diagnostic System | Plasma Pathogen Inactivation |
| Cardiac Ablation System | Hospital Bed and Operating Room Mattress Pads/Surfaces | Point of Care Diagnostic Meters |
| Cardiac Assist | Hospital Information Systems (HIS) Interface | Pulse Oximeters |
| Dental Implant Imaging System | Hospital Infusion Pumps | Radiation Treatment Planning Systems |
| Diabetes Glucose Meters and Insulin Pumps | Hospital Patient Monitors | Robotic Surgical Control System |
| Dialysis Systems | Implanted Heart Defibrillator and Pacing Systems | Slide Stainer Management |
| DICOM - Capture, Analysis, and Display | Intraocular Lens (IOL) Test Fixture | Stem Cell Growth Systems |
| DNA/RNA Diagnostic Systems | Lab Information Systems (LIS) Interface | Stereotactic Radiosurgical/ Radiotherapeutic Systems |
| ECG Holter Monitors | Magnetic Navigation System | Sterilization Systems |
| EEG Monitoring | Mammography Systems | Ventricular Assist Devices |
| Endoscopic Surgical System | Migraine Patch | Wireless EEG |
| Ambulatory Infusion Pumps |
| Arthrombic Pumps |
| Artificial Heart |
| Bioimpedance Instruments for Lymphedema |
| Blood Cell Counters |
| Blood Chemistry Analyzers |
| Blood Parameter Monitoring Systems |
| Cardiac Ablation System |
| Cardiac Assist |
| Dental Implant Imaging System |
| Diabetes Glucose Meters and Insulin Pumps |
| Dialysis Systems |
| DICOM - Capture, Analysis, and Display |
| DNA/RNA Diagnostic Systems |
| ECG Holter Monitors |
| EEG Monitoring |
| Endoscopic Surgical System |
| Enteral Nutrition Pumps |
| External Heart Defibrillator System |
| Flat Panel X-Ray Systems |
| Gamma Cameras |
| Glucose Meters & Patient Software (PC and Web) |
| Hearing Systems |
| HIV Diagnostic System |
| Hospital Bed and Operating Room Mattress Pads/Surfaces |
| Hospital Information Systems (HIS) Interface |
| Hospital Infusion Pumps |
| Hospital Patient Monitors |
| Implanted Heart Defibrillator and Pacing Systems |
| Intraocular Lens (IOL) Test Fixture |
| Lab Information Systems (LIS) Interface |
| Magnetic Navigation System |
| Mammography Systems |
| Migraine Patch |
| Neonatal Incubators |
| Neurostimulator - embedded software and programmer |
| Nuclear Medicine Imaging |
| Optical Biopsy System |
| Optical Coherence Tomography |
| Pain Management |
| Plasma Pathogen Inactivation |
| Point of Care Diagnostic Meters |
| Pulse Oximeters |
| Radiation Treatment Planning Systems |
| Robotic Surgical Control System |
| Slide Stainer Management |
| Stem Cell Growth Systems |
| Stereotactic Radiosurgical/ Radiotherapeutic Systems |
| Sterilization Systems |
| Ventricular Assist Devices |
| Wireless EEG |
We look forward to talking with you!
We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!