Market access & 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.

Assumption of responsibility as Authorised Representative (EC-REP according to Article 11 MDR)

A medical device manufacturer established outside the EU must appoint an Authorised Representative (EC-REP) established in the EU to fulfil the requirements for placing medical devices on the EU market in accordance with the MDR (Article 11).

For these manufacturers, the authorised representative plays a central role as their contact person established in the Union. In case of requests from EU authorities, this authorised representative is contacted and has to ensure that the requests and all required information are provided and handled correctly.

TentaConsult assumes the role of authorised representative and competently handles all related activities and formalities on behalf and in the interest of the manufacturer.

If you are a manufacturer of medical devices that you want to supply to the EU, please contact us and we will talk about a potential cooperation.

Clinical evaluations up to risk analysis

A central aspect of the technical documentation for the conformity assessment procedure is the Clinical Evaluation, for which we prepare, for example, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Reports (CER). With literature-based Clinical Evaluations, we efficiently fulfil the requirements of the Notified Bodies and, if necessary, advise on the design of further studies.

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.

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    Regulatory Affairs
  • Quality Management

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

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    Quality Management
  • Clinical & Medical Affairs

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

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    Clinical Affairs TentaConsult
  • Vigilance & Surveillance

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

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    Vigilance - Surveillance TentaConsult
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