Academia is a place where breakthroughs and overthrow of the existing scientific paradigms is an everyday bread. Exciting things occur, every time science meets technology. The field of medical devices and IVDs is no exception to that.
Young and dynamic scientists very often do not realize, however, that there is a considerable difference between the invention and the marketed product. This gap frequently turns out to be a dangerous marathon, which only a few of the young inventors are able to eventually finish and call themselves successful.
The reason why this race is often difficlut for so many brilliant ideas and technologies is the lack of know-how about the regulatory and quality aspects related to bringing the idea to the market. Scientists, young inventors, and entrepreneurs are very rarely aware of all the pitfalls that await them and their product along the process.
From successful Quality Management System implementation, through well-organized design and performance of clinical instigations, and finally product registration to end up with, all of the aforementioned stages need not only careful planning but also an efficient execution.
Medidee has a long and successful track record of collaboration with startups and young scientists, that at one point in time decided to make a difference in the field of medical devices or IVD. Our broad expertize in quality, regulatory and clinical affairs enables our clients to successfully close the gap between their brainchild and the actual product.
With Medidee the race is way safer and turns into a steady and conscious march towards international markets.
Ambitious scientists, with innovative and groundbreaking ideas, who are lost in the ocean of regulatory and quality affairs have a companion for the road ahead. Medidee assists Scientists with closing the gap between an idea and a product.
Medidee collaborates with the scientific community (LSZSN, BSL and ADSV), to bring the awareness of the ever-changing regulatory landscape and requirements.