Finnish health technology company Monidor Oy specialises in the development of
medical devices. Its main devices are an infusion meter and IV Screen remote
monitoring solution, which help the work of nurses and improve patient safety in
intravenous (IV) therapy.
When we were designing the first generation of the device back in 2016, our partner
responsible for the mechanical design recommended working with Gelecta to source the mechanical components.
– For us, Gelecta is an important additional resource. Through Gelecta’s network, we
found a highly-skilled manufacturer of mechanical parts in China. Gelecta deals with the
negotiations and practical matters with manufacturers on our behalf, leaving us to focus on our own specialisation – the development of devices and software, says Seppo Puolitaival, Monidrop product manager at Monidor Oy.
The infusion meter and complementary IV Screen remote monitoring solution is a medical device with a measuring function and is therefore classified as a Class Im device. Class Im requires certification by a notified body.
– A company making medical devices must conform to the ISO 13485 quality standard.
The design and manufacture of medical devices are subject to very strict criteria. Similarly, the manufacturer of individual product components needs to understand and comply with the requirements of standards. Reliability and quality play a vital role in the manufacturing process, Puolitaival sums up.
Monidor Oy is a health-technology company founded in 2015. Our products are small, smart medical devices and digital health solutions. Our passion is to help the clinicians in their work and improve patient safety with simple solutions.