Röchling Medical has established a state-of-the-art NPI process which guarantees the highest quality and timely delivery for product development and industrialization activities. We are an experienced partner when it comes to the design, development and manufacture of high-quality medical and pharmaceutical products.
Röchling Medical's NPI system includes procedures, processes, guidelines, work instructions and templates for all new product and technological innovations, as well as all related project management, quality planning and steering tasks. The NPI takes the requirements of GxP and other relevant regulations into account in every phase.
Our NPI process has integral milestones/stage gates designed to reduce project risk.
The benefits of our NPI System are:
Flexible and scalable procedures, suitable for both simple and complex projects
Different starting positions with key action points and defined input & output phases depending on the complexity of the product and the process requirements
Milestone/stage gate approach to reduce project risk
Robust process validation procedure that complies with cGMP / FDA / ISO 13485
ISO 15378 certification – Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001 with reference to good manufacturing practice (GMP)
ISO 13485 certification – Medical devices – Quality management systems – Requirements for regulatory purposes
Based on proven program management practice