PROJECT EXAMPLES
NOTHING IS MORE CONVINCING THAN REALITY
Our success with the realisation of medical technology projects speaks for itself. You can filter the references by your field of activity or the technology that interests you:
Contrast medium injector for CT
The Contrast Medium Injector was developed by seleon for the intravenous injection of contrast media and isotonic saline solutions for computer tomography in the context of an examination with CT and CT-PET scanners.
Calibration station for gas mixer (EGM)
Optimisation of the product lifecycle management processes
Potential analyses
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FDA approvals and coaching
Complete revision/generation of the software documentation for the FDA approval of (in part also older) existing products
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Adaptation of products to changed regulatory requirements
Adaptation of a world-leading medical technology group’s existing products to account for regulatory changes from IEC 60601-1, 2nd to 3rd edition
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CPAP, AutoCPAP, bi-level CPAP – devices for the treatment of sleep apnoea
CPAP devices are used to prevent apnoea while sleeping.
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Stent coating system
Several steps can be completed in one with the device. The protective cap is removed from the stent with the operation of the lever, and at the same time, the drug is applied and dried with sterile oxygen.
Haemo Base
The aim of the research project 'Haemo Base' was to develop an analysis unit to be used in a hemodynamic measurement station in the cardiac catheterization laboratory.
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TNI®20 – therapy with nasal insufflation
The TNI®20 is used for sleep-related breathing disturbances. It was developed as a highly comfortable alternative to breathing therapy devices on the market.
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Home ventilation
Strict requirements are imposed on the development of an air humidifier for home ventilation: adequate warming and humidification of the breathing air while simultaneously preventing possible condensation of the humidified air in the ventilation hose.
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Intensive ventilation with humidified air
Breathing air conditioning, meaning the warming of breathing air to 37 °C with simultaneous humidification to nearly 100%, is among the key issues in patient ventilation.
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Measuring module for the synchronisation of ECG data
For a new generation of CT scanners, a Physiological Measurement Module (PMM) was developed and manufactured for the synchronization of CT imaging with the respiratory or heart rate of the patient.
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Digital gas mixer for ventilation and anaesthesia equipment
The Digital Gas Mixer is used to produce specified oxygen concentrations (from compressed air and oxygen) or mixtures of no more than four gases.
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Oximeter for the local measurement of oxygen saturation in the blood
The Oximeter is a measuring device to determine the local oxygen saturation in the blood. It is used at a heart catheter measuring station.
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Adaptation of products to changed regulatory requirements
A leading manufacturer in the automation technology market wants to enter the medical technology field.
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Market surveillance, vigilance, post-market clinical follow-up
Assuming manufacturer obligations in the areas of market surveillance, vigilance and post-market clinical follow-up for numerous smaller medical device manufacturers
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Airsens – modifiable pressure sensor
Togehter with the HSG-IMIT, seleon gmbh has developed a new generation of flow sensors with very low flow rates and fast response.
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Software to support the anaesthesiologist
The software developed by seleon supports the anaesthesiologist in the prozess of guiding thepatient through anaesthesia.
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Cardiological rehabilitation software: XRCISE CARE
The XRCISE CARE software encompasses versatile and flexible training control in cardiological rehabilitation. Up to 24 patients can be monitored and their therapy devices controlled with this software.
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Device development for telemedicine
A base station called the "Health Buddy" is installed for a patient at home. The Health Buddy measures and transmits daily vital signs, symptoms, behaviour and knowledge of the patient.
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SPECIMEN HANDLING ROBOT
The performance and capacity of a robot that transports test tubes were tested using a functional model of the robot. Costs and the technology were optimised using a subsequent functional model.
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airtrust® med – air compressor
The airtrust® med is a quiet, compact and powerful air compressor intended to supply clinical ventilators with clean, high quality compressed air.
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Scope Pilot – interactive test device for endoscope preparation
The device provides the user with standardised, interactive guidance through the endoscope preparation process. Carrying out the actions is recorded and documented.
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Pre-clinical and clinical evaluations
Preparation and maintenance of clinical evaluations for numerous smaller medical device manufacturers who lack regulatory expertise in this field.
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FDA approvals and coaching
Approval of tanning products (tanning booths) as medical devices in the USA, where they were previously approved as wellness products.
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Adaptation of processes to modern development technologies
Introduction of Scrum in the software development process for medical device software in compliance with EN 62304 and EN 60601-1, Section 14 (PEMS)
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Project management subject to compliance with times, costs and the quality of medical devices
Mentor training for project managers
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Optimisation of the product lifecycle management processes
Continuous improvement process
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Complex risk management and sophisticated safety concepts
Development of a functional safety concept using a novel risk management approach for a mobile defibrillator
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3D HD video processing system
For training purposes, the activities completed during (eye) operations have to be transferred to systems outside the operating room.
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Electronic gas mixer
The Electronic Gas Mixer supplies premature infants with pure oxygen and inert gases.
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Dental Laser (Elexxion)
This project was for a surgical laser in the dental field.
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Heart catheter measuring station
With the Heart Catheter Measuring Station, seleon offers an integrated package for heart catheter examination procedures.
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Physiological measuring module
The PMM makes it possible to take images accurate to the split second during elaborate MRT and CT examinations without exposing the patient to unnecessary additional radiation.
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Skin treatment device (LEDA)
The Skin Treatment Device is used primarily in the context of dermatology.
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Ventilator (TNI 2.0)
The ventilator is used to provide both air and humidity.
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airtrust® med
The airtrust® med ensures the autonomous supply with medically pure air.
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Preparation and maintenance of technical documentation
A manufacturer of innovative complementary medical devices wants to have its products approved nationally and internationally
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Laser amplifier/
frequency amplifier
This is a frequency amplifier that boosts the output of a laser for a laser application.
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