ARTCLINE is certified according to ISO 13485

ARTCLINE always places great importance on high quality in all projects and processes. The company is now certified according to EN ISO 13485 by MEDCERT.

MEDCERT is one of the largest certification companies and notified bodies in Germany in the medical device industry.

ISO 13485 is a worldwide standard especially for the medical device industry. The European standard EN ISO 13485 specifies the requirements for a quality management system (QMS) of a medical device developer and manufacturer. This standard focuses on the safety of the products and the fulfillment of legal requirements.

The standard is divided into five main chapters:

  • Quality management
  • Responsibility of the management
  • Management of resources
  • Product realization
  • Measurement, analysis and improvement

“A successful certification demonstrates our corporate development and helps to continuously develop processes and medical device products in the future. Thus, we ensure the reliability and quality of all our processes.” commented Dr. Altrichter, CEO of ARTCLINE.

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