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Röchling Medical Quality Systems

NPI System

Röchling Medical is experienced partner for the design, development and manufacturing of high quality medical and pharmaceutical products. We have established a cutting edge NPI process to ensure a high quality and on time delivery for product development and industrialization activities.

The NPI system includes procedures, processes, guidelines, work instructions and templates for all new product innovation and new product introduction activities and includes all the related project management and steering task. The process includes embedded milestone / gate stage to de-risk the projects.

The highlights of the NPI System are:

  • Flexible and scalable procedures, best fit for purpose solutions to cover simple and complex projects (3 different complexity tracks)
  • Different starting points with key action points and defined input & output per phase
  • Milestone / gate stage approach to de-risk the projects deliveries and the related investments
  • Robust and cGMP / FDA / ISO 13485 conform validation procedure
  • Certified according to ISO 15378, which defines the high requirements for the production of pharmaceutical packaging
  • Based on proven program management practice


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Dominic Garrecht
Head of Regulatory Affairs / Head of Quality Management