We worked with Sphere Medical throughout the development of the product, first designing a research version, followed by the CE-approved Pelorus 1000 and, most recently, the IVD CE-approved Pelorus 1500.
Sphere Medical specialises in innovative medical monitoring and diagnostic equipment. Sphere approached eg technology with an emerging product which required additional development. eg technology were commissioned to develop the Pelorus instrument to make it suitable for CE approval as an in vitro diagnostic (IVD) medical device.
Sphere Medical’s goal is to allow near real-time measurement of blood gases, electrolytes and drug levels with laboratory accuracy, at the patient’s bedside. Sphere Medical approached eg technology with a challenge to deliver the redesigned Pelorus within four months to meet their business plan.
time critical project | ce approval | real-time measurement | in vitro diagnostic medical device
The project required a number of mechanical, electronic and fluidics changes to bring it up to the approved IVD standard. In addition to these redesigned elements, the design team completely reworked the software in order to achieve compliance with IS06234:2006 and allow CE marking. The software test documentation required for CE approval was also produced.
electronics engineering |mechanical engineering | Software Development | Industrial Design
The Pelorus 1500 has been CE marked as a fully approved IVD medical device and offers the unique capability to rapidly measure the concentration of the intravenous anaesthetic propofol in whole blood samples. Despite the significant time constraints, eg technology delivered the project on time and within budget.
The Pelorus Instrument is the world’s first commercially available device that allows real-time measurement of the concentration of propofol, the powerful intravenous anaesthetic, in the patient’s blood.
“I was very impressed with the close support and flexible approach demonstrated by eg technology during the project, as well as the range of technical capability they brought to the project.” Dave Walters | Project Manager | Sphere Medical
For further information on how eg technology can support your MedTech solutions, please get in touch.
eg technology are ISO 13485 accredited. We put rigorous quality management at the centre of everything we do, providing our clients with the compliance to standards for safety, quality, risk management and traceability.