The presentation of the processes around the Medical Device Regulation (MDR), which will now become valid on 26 May 2021 after a one-year postponement, is complex and not always transparent, especially for young market participants (company founders, university start-ups or spin-offs, small manufacturers).
The TentaStart model of the Tentamus Group is specifically tailored for this target group and is now complemented by the great professional expertise as well as many years of market experience of TentaConsult in the field of medical devices. “Just in time to help these clients to overcome the often great disorientation of small companies in a legal framework that is already extremely complex due to the transition from the MDD (Medical Device Directive) to the MDR, we have decided to offer the service already established in other product areas for medical devices at very short notice,” explains Ralf Sibbing, Managing Partner of TentaConsult Pharma & Med, which specialises in consulting and services for healthcare 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. So, we want to make the start of cooperation with us particularly rewarding and, above all, uncomplicated with a full-service offer – precisely supported by the accredited laboratories of the Tentamus Group – and an attractive introductory price for this target group,” Anja Heinrich of TentaConsult explains further.
In the first year of cooperation, TentaStart grants a 10 % discount on all prices for consulting and services as well as the analyses of the Tentamus laboratories. An individual initial consultation on the principles of conformity assessment and first placing on the market is of course included for start-ups.
Contact our expert for TentaStart on medical devices. We look forward to helping you.
+49 251 928 715 62