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Legal manufacturer for your medical technology product.

Why a legal manufacturer as a service provider?

The transition from MDD to MDR poses challenges for the entire industry. Meeting the high requirements requires time, costs and (new) expertise. Factors that more and more companies cannot afford. From staff growth to rising audit costs.

According to a BVMED survey, over 70% of the members surveyed have already discontinued individual products or entire production lines in 2021 due to the new MDR regulation.

But without these or new medical devices, we will lose valuable innovations that damage us socially and economically in Germany and Europe.
‍source

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The solution: Outsource the process (or sub-processes) and comission an external legal manufacturer. That is exactly where we want to start.

Why we as Legal manufacturer?

As a manufacturer, you can hand over the responsibility, liability and thus also the pressure that a market launch and subsequent support entails to us.
As your partner, we work with you from the very first meeting to develop the ideal, individual approach for your product.
In close coordination with you, we take care of all necessary measures to get your product on the market and support it right through to the end.
You not only actively save work when increasing personnel or carrying out audits, market monitoring and QM system maintenance, but also passively — for example when archiving technical files. In return, you get a competent partner who will temporarily or completely take care of all of this and much more for you.

Presentation services bytec LM
Developing a joint concept for product launch

Why we as EC-Rep?

We can also act as a legal representative for companies outside the European Union. As an internationally experienced team, we know the European market, are familiar with most regulations or can update ourselves within a short period of time.
In addition, we are directly on site and can therefore also make your product available in one of the largest markets worldwide.