Electronic Medical Devices
FDA Approval, Paragon Can Help
Ventricular Assist Device
Cardiac Support Pump "This device uses an electro-pneumatic system to provide an extra ""push"" for weakened heart muscles."
Advanced Hemodynamic Monitor
Cardiac Patient Monitoring System FDA approved device that combines continuous cardiac output monitoring with various other critical cardiac parameters in a single device.
Tissue Oximetry Module
Monitors oxygen saturation Expansion module for Edwards monitoring systems that allows state of the art Tissue Oximetry readings.
Insulin Pump Design 508
Wearable Insulin Pump FDA Approved Wearable Insulin Pump allows diabetic patients to receive insulin at a steady rate and improves patient outcomes.
Paradigm Insulin Pump Design
MiniMed Medtronic FDA Approved Wearable Insulin Pump
Vista Infusion Pump V & V Testing
FDA V & V Test Protocol Review "Paragon was able to evaluate and review B. Braun's procedure, to ensure they would pass the stringent development and verification process that is required for the products they produce."Learn More
Outlook Infusion Pump Development Project
FDA approved enhancements An automatic configurated system was successfully designed that is now able to reduce drug delivery mistakes which are able to prevent harm or possibly death of patients.Learn More
Ophthalmic Laser Photocoagulation
User interface test system. This device was used by Alcon Labs to develop and test an Ophthalmic Laser Photocoagulation system with clinicians.Learn More
Electroporation Medical Device
Invivo Electroporation System This FDA approved medical device is used to provide genetic therapy in patients by using electroporation to allow treatments to reach inside cell walls.Learn More
Vigilance Continuous Cardiac and SvO2 Monitor
Cardiac Monitoring System This FDA approved cardiac monitoring system used DSP and precision control systems to provide continuous cardiac output data.Learn More
Vigilance Functional Test System
Functional Test System "This functional test system allows data collected from clinical and animal trials to be ""replayed"" to the device under test, allowing regression testing and factory calibration."Learn More
Myocardial Protection System
Cardiac Support System FDA approved device provides life sustaining nutrients to the heart while a patient is on bypass during open heart surgery.Learn More
Blood Pressure Monitor
Patient Monitoring System Fiberoptic intravenous blood pressure monitor. This system also provided outputs which emulated traditional blood pressure systems.
We have helped startups to large medical companies develop a wide range of medical devices. When it absolutely has to work, we are the team to get it done.
Getting through FDA requirements requires meticulous planning from day one. It's time-consuming, it's expensive and if you don't start on the right path from the beginning you may find yourself back at the starting line even after you've developed a prototype. You need an expert in your court all the way through this process.
At Paragon Innovations, we have a passion for the design and development of medical electronic device products. Our experience spans years of providing our clients the very best in medical device design and engineering, which has included insulin pumps, cardiac output monitors, pulse oximeters, ultrasonic diagnostics, micro-pulse radar, handheld medical devices, and more. Our goal is to help our clients develop medical device products that are more reliable, higher quality and more cost effective on the most efficient path possible.
Our engineering development team has:
- Extensive background in medical device design
- Passion for customer-focused medical device usability
- Proven experience with verification testing and FDA design documentation requirements
- In the field experience and cross-market knowledge to offer unique design perspective
We are experts in:
- FDA Approval
- ISO 13485 / IEC 60601 / IEC 62304
- Electronic Medical Devices
- Medical Product Development
- Cardiac devices
- Diabetes products
- Insulin Pumps
- Infusion Pumps
- Myocardial Protection Devices
- Continuous Cardiac Output Devices
- Medical Vision Systems
- Invasive Sheath Based Optical Blood Pressure
- Electronic Medical Device
- Medical Product Development
- Invasive Blood Pressure
We have been externally audited to ISO 13485 and ISO 9001 compliance, and our medical device design and development experience extends across the entire product development life cycle. We can help you go from product concept all the way to production. Our engineering team can provide a complete turnkey development.
Check our case studies to see some of the medical devices we've developed