Regulatory & Medical Affairs

Do you need to make your product ready for the medical device market? Do you need support when it comes to design transfer and serial production? We are ready to take responsibility to realize production and product approval under MDR and other regulations.

R&D / F&E

  • strategic leadership & operation
  • Marketing, Product Placement, Product claims, market entry strategy, markets and competition analysis, market and product launch

Regulatory & Medical Affairs

Preparation of Technical Documentation and Quality Management System (QMA) according to

  • Medical Device Directive (MDR, 2017/745/EU)
  • In-Vitro-Diagnostika (IVDR), 217/746/EU)
  • QSR (21 CFR 820

As a result, you receive a complete dossier of the Technical Documentation and a well working QMS- System and your CE-conformity / FDA clearance.

All solutions are provided separately or as combination – this is your decision!

Project Management

Fast comprehension, flexible operation and target-oriented strategy – markets and more offers experience, know-how and strategic support within the following business areas:

We offer experience, know-how and strategic support in the following business fields:

  • Operation in specified projects
  • Support with quality management processes
  • Concepts and instruments for the optimization of internal company processes
  • Concept, instrument analysis and evaluation of business structures and processes