Manufacturing & Quality

Manufacturing & Quality

100% quality focused manufacturing

Nemera’s industrial teams share a belief that the devices they manufacture have an impact on patients’ health. That is why quality is so critical for them. It results from the commitment of strong global quality teams, compliance with cGMP and other regulations, and state-of-the-art equipment. It is taken into account at all stages, from the risk-based approach of product design to the implementation of the manufacturing process, and 100% online testing.

All four industrial sites are rated every month in the Challenge 10,000. This comprehensive quality rating assesses the sites’ capacity to :

  • deliver on time and accurately the world over,
  • secure full operator safety, not only from major but also minor incidents,
  • fully satisfy customers, and ultimately patients.

Challenge

Three questions to Christian Meusinger, VP Quality, Regulatory and Compliance:

Why is quality so important for Nemera?

Our Quality is made by people for people who trust the functionality and effectiveness of our products and devices. Quality is the key driver in our organization to ensure that patients will receive the best product and service possible.

What are the differentiating measures you take to secure quality?

Quality is a result of highly capable processes and efficient systems. Based on Risk Assessments we are focusing early on to design capability into our processes in order to minimize process variation and eliminate deviations. Regular trending of our processes along with selected product controls are applied to confirm product conformance and performance, unit by unit.

How can you illustrate your achievements in terms of quality?

Significant reductions of customer notifications up to 30% year on year are the primary indicator to evaluate how we are doing in our quality performance. We also track other leading indicators only developed with the key objective of eliminating critical defects, reducing the number of deviations and finally ensuring customer satisfaction. Customer survey results and the improvements achieved give us confidence that we are on track to achieve our goals.

Over 1,300
employees
4 plants in Europe
and IN the USA
Over 30,000 SQM clean room
manufacturing