The presentation of the processes relating to the Medical Device Regulation (MDR), which will come into effect on May 26, 2021 after a one-year postponement, is complex and especially for young market participants (company founders, university start-ups or spin-offs). Offs, small manufacturers) not always transparent.
The TentaStart model of the Tentamus Group is specially tailored for this target group and is now being supplemented by TentaConsult's extensive technical expertise and many years of market experience in the field of medical products. “Just in time to straighten out the often great disorientation of small companies in what is already an extremely complex legal framework for these clients due to the transition from the MDD (Medical Device Directive) to the MDR, we decided to change the legal framework for other product areas to offer already established service for medical products at very short notice, ”explains Ralf Sibbing, Managing Partner of TentaConsult Pharma & Med, which specializes in consulting and services for health products in the Tentamus Group.
“We know that the application of the new Regulation (EU) 2017/745 is a particularly big headache for many young market participants in particular. With a full-service offer - precisely supported by the accredited laboratories of the Tentamus Group - and an attractive entry price for this target group, we want to make the start of cooperation with us particularly rewarding and, above all, uncomplicated, ”explains Anja Heinrich from TentaConsult.
In the first year of cooperation, TentaStart grants a discount of 10% on all prices for advice and services as well as the analyzes of the Tentamus laboratories. An individual initial consultation on the principles of conformity assessment and the initial placing on the market is of course included for start-ups.
Anja Heinrich
anja.heinrich@tentaconsult.com
+49 251 928 715 62
