Update from Andy19 Feb 2021 18:28
Tired of your evidence base being plagiarised by your competitor? Change is coming!
Deltex, like so many other Life Science companies, is transitioning from MDD to MDR. In completing our Clinical Evaluation Report we finally see some upside to the increasing regulatory burden and cost.
Here’s why: MDR will have a positive impact on us and many companies like us who continually have their clinical evidence plagiarised by competitors who claim ‘equivalence’ to support their own technologies… despite none existing.
MDR clearly defines clinical equivalence as ‘the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements’.
Therefore to those companies who have historically used the evidence base conducted on the Oesophageal Doppler Monitor to validate their own, very fundamentally different technologies, it’s now time to invest in building your own specific clinical evidence base.