Electronic Medical Devices

FDA Approval, Paragon Can Help

Advanced Hemodynamic Monitor

Cardiac Patient Monitoring System This FDA approved device combines continuous cardiac output monitoring with critical cardiac parameters in a single device.

Edwards Hemosphere Advanced Hemodynamic Monitor

Paradigm Insulin Pump Design

MiniMed Medtronic FDA Approved Wearable Insulin Pump

Paradigm Insulin Pump Design

Ventricular Assist Device

Cardiac Support Pump This device uses an electro-pneumatic system to provide an extra “push” for weakened heart muscles.

CorInnova VAD Ventricular Assist Device

Insulin Pump Design 508

Wearable Insulin Pump This FDA Approved Wearable Insulin Pump allows diabetic patients to receive insulin at a steady rate and improves patient outcomes.

Insulin Pump Design Model 508

Vigilance Continuous Cardiac and SvO2 Monitor

Cardiac Monitoring System This FDA approved cardiac monitoring system uses DSP and precision control systems to provide continuous cardiac output data.

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Vigilance Continuous Cardiac and SvO2 Monitor

Myocardial Protection System

Cardiac Support System This FDA approved device provides life sustaining nutrients to the heart while a patient is on bypass during open heart surgery.

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Myocardial Protection System

Electroporation Medical Device

Inovio Electroporation System his FDA approved medical device provides genetic therapy in patients using electroporation to allow for treatments inside cell walls.

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Electroporation Medical Device

Blood Pressure Monitor

Patient Monitoring System A Fiberoptic intravenous blood pressure monitor that provides outputs that emulate traditional blood pressure systems.

Endophys BPM Blood Pressure Monitor

Outlook Infusion Pump Development Project

FDA approved enhancements A successfully designed automatic and configurated system can reduce drug delivery mistakes to prevent harm or possibly death of patients.

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Outlook Infusion Pump Development Project

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."

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Vista Infusion Pump Verification and Validation

Ophthalmic Laser Photocoagulation

User interface test system. Alcon Labs used this device to develop and test an Ophthalmic Laser Photocoagulation system with clinicians.

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Ophthalmic Laser Photocoagulation System

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
  • SvO2
  • SpO2
  • Electroporation
  • Medical Vision Systems
  • Invasive Sheath Based Optical Blood Pressure
  • Electronic Medical Device
  • Medical Product Development
  • Electroporation
  • High fidelity arterial pressure monitoring

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