FreMon Scientific
FreMon Scientific is dedicated to the safe and efficient processing and use of lifesaving blood, plasma, and tissue products. They create platforms and devices that are easy to use, fast, low cost, and enable inventory management. Their mission is to improve and save lives through innovative medical devices, including the ZipThaw and ZipSleeve systems, which are dry, portable, and precise plasma thawing solutions used worldwide by blood banks, hospitals, military facilities, research centers, and veterinary clinics.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Portable dry blood/plasma thawing device
Compact electromechanical thawing system designed to thaw frozen blood and plasma products rapidly using embedded temperature sensors and independent warming chambers; intended as an alternative to circulating-water baths.
Single-use sterile sleeve with integrated temperature sensing
Disposable sterile sleeve that protects the device from contact with blood or plasma, incorporates an embedded sensor for temperature measurement, and is intended for single-use to reduce contamination and cleaning needs.
Portable dry blood/plasma thawing device
Compact electromechanical thawing system designed to thaw frozen blood and plasma products rapidly using embedded temperature sensors and independent warming chambers; intended as an alternative to circulating-water baths.
Single-use sterile sleeve with integrated temperature sensing
Disposable sterile sleeve that protects the device from contact with blood or plasma, incorporates an embedded sensor for temperature measurement, and is intended for single-use to reduce contamination and cleaning needs.
Services
Device demonstrations and user training delivered in-person at client sites or virtually, including instructional videos and quick-start materials.
Materials and resources provided to distribution partners to support sales, demonstrations, and post-sale support.
Coordination and oversight of production engineering and contract manufacturing for both device hardware and single-use consumables to support scale-up and regulatory compliance.
100% quality control testing and assembly-line inspection performed prior to shipment to ensure product conformity and to support regulatory documentation.
Limited product warranty with repair-or-replace remedy, return material authorization workflows, and authorized service provider model for defects and maintenance.
Device demonstrations and user training delivered in-person at client sites or virtually, including instructional videos and quick-start materials.
Materials and resources provided to distribution partners to support sales, demonstrations, and post-sale support.
Coordination and oversight of production engineering and contract manufacturing for both device hardware and single-use consumables to support scale-up and regulatory compliance.
100% quality control testing and assembly-line inspection performed prior to shipment to ensure product conformity and to support regulatory documentation.
Limited product warranty with repair-or-replace remedy, return material authorization workflows, and authorized service provider model for defects and maintenance.
Expertise Areas
- Dry thermal thawing systems for blood and plasma products
- Clinical validation and comparative testing for transfusion devices
- Medical device production engineering and contract manufacturing coordination
- Regulatory compliance and standards for medical devices (FDA 510(k), CE/MDR, ISO 13485, transfusion standards)
Key Technologies
- Dry thermal thawing with embedded product temperature sensors
- Direct product temperature monitoring and logged thaw profiles
- Controlled-rate thawing and thermal control algorithms
- Modular multi-chamber electromechanical warming systems
News & Updates
ZipThaw is FDA 510k cleared, CE Marked, ISO 13485 certified, UL listed, and rated as AABB Standards-Compliant, making it a safe, effective, and portable blood product thawing device.
FreMon Scientific has made significant progress towards FDA clearance and CE Mark certification for ZipThaw and ZipSleeve, with successful safety and reliability testing.
ZipThaw is a dry, portable, and precise plasma thawing device that is FDA cleared, CE Marked, and compliant with industry standards, offering a safer and more efficient alternative to water baths.
The FDA has announced that convalescent plasma may be useful for treating COVID-19, and ZipThaw is the ideal device for thawing plasma safely and quickly.
ZipThaw has passed multiple ISO recertification audits with zero notes, confirming its safety, quality, and compliance.
ZipThaw received FDA 510k clearance for clinical use, confirming its safety and effectiveness as a blood product thawing device.
ZipThaw is FDA 510k cleared, CE Marked, ISO 13485 certified, UL listed, and rated as AABB Standards-Compliant, making it a safe, effective, and portable blood product thawing device.
FreMon Scientific has made significant progress towards FDA clearance and CE Mark certification for ZipThaw and ZipSleeve, with successful safety and reliability testing.
ZipThaw is a dry, portable, and precise plasma thawing device that is FDA cleared, CE Marked, and compliant with industry standards, offering a safer and more efficient alternative to water baths.
The FDA has announced that convalescent plasma may be useful for treating COVID-19, and ZipThaw is the ideal device for thawing plasma safely and quickly.
ZipThaw has passed multiple ISO recertification audits with zero notes, confirming its safety, quality, and compliance.
ZipThaw received FDA 510k clearance for clinical use, confirming its safety and effectiveness as a blood product thawing device.