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Certification

NICOLAY is certified according to:

  • EN ISO 13485:2016 + AC:2016 – ISO 13485:2016
  • DIN EN ISO 14001:2009

We live quality, environmental protection and occupational safety

All business processes are integrated into the integrated NICOLAY management system (quality, environment and occupational safety) and form the basis of our daily work.

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Quality Assurance

Quality as a basic requirement for your market success

Our quality department supervises the product developments from the initial samples to series production. This takes place in the form of initial sample tests, lifetime tests, 3D dimensional and PC colour tests, tests in accordance with IEC 60601-ff and AAMI, tests specified internally and by the customer as well as biocompatibility tests of the materials used.

The tasks of NICOLAY’s quality assurance department also include the following tasks:

Statistical incoming goods inspection of all purchased parts and assemblies
Conducting intermediate tests to ensure production quality
The 100 % electrical, optical and functional final product inspection
All this is carried out with the help of computer-controlled testing equipment.

Contact us immediately if there is a reason for a complaint. We see this as an opportunity for further improvement.

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Policies

As one of the world’s market leaders in the development and manufacture of medical devices, accessories for non-invasive patient monitoring and diagnostics, NICOLAY GmbH is committed to ensuring the safety, health and protection of people and the environment all over the world.

Get in contact with us!

If you need further information, please contact us.