Authorization

Whether in an advisory or responsible capacity - we accompany you and your product on and through the (inter)national market. With our subsidiary bytec LM.

Authorization

Whether in an advisory or responsible capacity - we accompany you and your product on and through the (inter)national market. With our subsidiary bytec LM.

Services of bytec LM

Legal Service

The legal manufacturer is responsible and therefore also liable for the product. We can assume this position for you, along with the associated obligations that arise prior to the product launch and are associated with the availability of the medical device.

Responsibility

As a QMB, PRRC or authorized representative, we can provide you with short-term or long-term colleagues who can familiarize themselves with your existing structures and support you with their time and expertise in product launches, QM system maintenance and much more.

EC-Rep

As a European Representative, we can also act as a legal representative for companies from other EU countries within the European market. This means you have experts directly on site.

Consulting

We work with you to develop a customized QM system in accordance with ISO 13485 and the European Medical Device Regulations so that you can bring your product to market.

Your advantages

Few industries are as heavily regulated as medical technology. Any changes and extensions to these regulations (e.g. the transition from MDD to MDR) are therefore associated with changes in your companies that cost time, money and expertise. Costs that not everyone can or wants to bear.

To prevent important innovations from being lost as a result, we provide a solution by outsourcing various processes.

We provide you with experienced colleagues who will support you, individually tailored to your needs and your product, from approval to the end of the device life cycle.

Your partner

bytec Legal Manufacturer GmbH, or bytec LM for short, is a subsidiary of ours founded in 2024 that focuses as a service provider on supporting your product from start to finish.

Find out more here.

With the possibilities of BYTEC med and bytec LM, we are happy to offer you a complete package from the initial idea to the last device sold. However, you can also opt for a partial service from one or both companies at any time:

Development - Production - Service - Approval