We share our knowledge,
for your success!

Choose your consulting focus ...

What we can do for you ...

... contact us today!

From idea to approval

Throughout the entire development phase of your medical device, we support you in the areas of regulatory affairs, strategy and project management.

Technical documentation

We support you in setting up the technical documentation for your medical device in accordance with MDR and international regulations.

Establishing QM systems

Lean and effective - We work with you to develop your customized quality management system and also support you with certification and maintenance.

Consulting

We offer you individual advice on all aspects of quality management and medical devices. Please contact us for a free initial consultation.

The Company

 Expertise from industry and science this is what K & S Consulting GmbH stands for.
We are characterized by years of experience in quality management, research and development as well as regulatory affairs. We would like to share this knowledge with you to drive your success!

Niklas Köhler, M. Sc.

Managing Director | Expert for strategizing

Prof. Dr. Michael Scholtes

External Consultant | Expert for Regulatory Affairs & Quality

References

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