Quality Guidelines of OSARTIS GmbH

As a manufacturer of medical devices, OSARTIS GmbH focuses all its thoughts and actions both on customers’ confidence in the quality of its products, and therefore on the wellbeing of patients, and also on customers’ satisfaction with products and services.

Our quality management system in accordance with DIN EN ISO 13485 aims to ensure that our high-quality products are developed and optimised as a result of constructive and trust-based collaboration with our customers at an early stage. This is based not only on customers’ requirements and compliance with the standards, regulations and country-specific specifications but also on conserving natural resources and the environment.

Our products are manufactured using efficient and cost-effective production methods, with the help of qualified and committed employees in line with processes specified and validated in our QM system. We use only high-quality materials from qualified suppliers to guarantee a high level of product safety and efficiency. Regular monitoring of product characteristics and design ensures consistent quality. Prevention of mistakes rather than remediation of mistakes is at the forefront of all QM measures.

With our forward-looking approach and by continuous improvement, we not only incorporate our customers’ proposals but also feedback from the market and in-house suggestions so that we can optimise the quality of our products on an ongoing basis. A key feature of our quality policy is to manufacture products and provide services that satisfy the highest quality requirements, in order to win and retain our customers’ confidence and satisfaction and also to ensure the safety of patients.

Certificates

As a manufacturer of medical devices, we hold the following certifications which can be downloaded as PDF documents at the link provided:

  • EN ISO 13485:2012 + AC:2012
  • ISO 13485:2003

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