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Presentation Legal Service

Would you like to act as a manufacturer yourself?

We are happy to advise you on all important steps in quality management or regulatory affairs.

Quality Management System

In order to act as a manufacturer yourself, a good QM system is one of the basic requirements.
We develop a customized QM system for you in accordance with ISO 13485 and the European Medical Device Regulations (MDR). This includes implementing all required processes as well as training your employees in them.
This way, you and we can ensure in the long term that your system and medical device meets all requirements in accordance with the regulation and that you pass the audits.

Apropos audit

Do you need support in preparing an audit at your company or with your suppliers? Regardless of whether it's a supplier audit, internal audit or audit preparation by an authority or notified body. We are at your disposal with know-how and experience.

This includes:

  • Joint preparation of an audit schedule and definition of the scope
  • Document review
  • Carrying out audits
  • Audit report collection
  • Defining and monitoring measures
Consulting for Regulatory und QM
team work

Regulatory Affairs

In the area of Regulatory Affairs, we advise you on all requirements, regulations and standards, from classification to clinical data, so that your product meets all regulatory requirements of the countries in which it is to be launched on the market. With the IVDR and the transition from MDD to MDR, we are currently focusing in particular on Europe.

We help you ...

  • to obtain the necessary approvals and clearances from regulatory authorities.
  • to understand and apply the relevant regulations and standards.
  • to keep your entry in the increasingly important EUDAMED database up to date.
  • to document and (re-)submit your clinical data in accordance with the new requirements.
  • to create a launch strategy tailored to your company.