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Strategies and services for Medical Devices

The Medical Device Regulation (MDR) has tightened the regulatory requirements for many established and safe products. Together with you we will find the right strategy for conformity assessment. We support you in assessing for which medical devices of classes I-III in your portfolio the changeover is worthwhile and whether the effort can be reduced, for example, through permissible literature references. For borderline products, we advise on questions of demarcation and identify attractive alternatives, but also suitable portfolio additions for our customers.

 

Market access and product maintenance with responsibility

The success and safety of your medical devices are in the best hands with TentaConsult. We create and maintain the necessary documents, documentation and QM systems. In short: We support you in all tasks and decisions up to market access – and also take personal responsibility beyond that.

 

On behalf we take responsibility:

 

We take over responsible roles:

 

Regulatory Affairs

We competently and reliably equip your pharmaceutical and healthcare products with all regulatory requirements for successful and rapid market access.

 

Quality Management

We support the establishment and optimisation of your QM systems and everything that goes with them in a responsible and experienced manner.

 

Clinical/Medical Affairs

We prepare meaningful clinical and medical reports and documentation for the scientifically substantiated assessment of your products.

 

Vigilance / Surveillance

We take responsibility for the safety monitoring and risk assessment of your products at every stage of their life cycle.

Tentamus laboratories in your vicinity