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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