Origin Medical Devices
Origin Medical Devices is committed to developing next-generation ventilator technology that is accessible to everyone. Advanced technology should be reliable, adaptable, and easy-to-use. From establishment, Origin Medical Devices’ mission was to develop a new generation of high-performance innovative ventilators that will create paradigm shift in the ventilation market.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Nationally (across the country)
About Us
Changing the world of ventilation
By combining a state-of-the-art blower with a patented proportional flow valve and specialized algorithms, the Panther ventilators deliver higher pressure, more flow, and precise breaths to the patient. With performance as good or better than any dual compressed gas source ventilator, the Panther 5 can support the sickest neonatal through adult patient.
Our core values are reflected by our purpose:
- Design with simplicity increasing reliability and accessibility
- Keep global audience at the center of what we do and continue to invest in development of devices and technologies to advance the standards of care
- Continuously strive to improve and think outside the box creating advancements in patient support and safety and streamlining overall clinical care
Our promise:
Origin Medical Devices will deliver advanced ventilators that perform to the highest standards without compromise.
Certifications
The Panther line ventilators are complied with the most updated medical standards. As of November 2020 here are is a list of certifications and standards:
- Panther 5 CE mark approval until 2024 by DEKRA
- Panther 5 FDA Emergency Use Authorization
- ISO 13485:2016
- EN 60601-1:2006/A1:2013 + A12:2014 (Ed 3.1) Medical electrical equipment – Part 1:General requirements for basic safety and essential performance
- EN 60601-1-2:2015 (Edition 4.0) Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 60601-1-8:2007 + A11:2017 Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- EN 62304:2006 + A1:2015 Medical device software - Software life-cycle processes
- IEC 60601-2-49:2011 Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
- EN 62366:2015 Medical devices - Application of usability engineering to medical devices
- ISO 80601-2-55:2011 Medical electrical equipment —Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO/CD 18562-1:2017 Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process
- ISO/CD 18562-2:2017 Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter
- ISO/CD 18562-3:2017 Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs)
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
- ISO 17664:2017 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medicaldevices
- ISO 10993 Biological evaluation of medical devices (replaced for respiratory devices by ISO 18652 Parts 1-3
- EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
- EU MDD 93/42/EEC Medical Devices Directive
- DIRECTIVE 2002/96/EC Waste electrical and electronic equipment (WEEE)
- Directive 2012/19/EU Waste electrical and electronic equipment (WEEE)
- Directive 2011/65/EU ROHS
- MEDDEV 2.7.1 Rev.4: 2016 Guidelines on medical devices: evaluation of clinical data
- MEDDEV 2.12/1 rev.8: 2013 Guidelines on a medical devices vigilance system