Support for Development and Industrialization

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A wonderful technical solution might solve your problem during the development phase. But it might not be the right one for the market? During the development phase, a lot of technical challenges occur which need your full attention. At the same time, regulatory, contractual, IP, manufacturability and costing aspects are critical for design transfer and industrialization. Not considering this right at the beginning means putting your business plan at risk by adding further development cycles. But who has the time to consider this? Our expertise can prevent typical strategic pitfalls during the development of medical devices.

  • Regulatory Strategy, legal Manufacturer
  • Functional Models Prototyping, Process Development, FMEA
  • Clinical Evaluations
  • Project Controlling and Risk Management
  • Design Controls, Technical Documentation
  • Interaction with Notified Body, Approvals