arcoro PROJECTS

Quality Management System in the dental sector

Company

The client is a leading software company that develops and operates CAD/CAM software for the dental sector. Originated from a research institute. Today part of a leading group of companies in the field of orthodontics. The company is active in more than 150 countries.

Competence area

  • Quality management

Project tasks

  • Introduction of quality management system according to ISO 13485
  • Consideration GxP Compliance
  • Analysis of the QA, QM and RA organization
  • Initiation CAPA process and documentation
  • Creation and structuring of technical documents
  • Preparation of risk management documents according to ISO 14971
  • Technical documentation / design documentation according to IEC 62304
  • Testing according to IEC 60601 (safety and ergonomic form)

Project duration

  • 4 months

 

We would be happy to compile further project references for you on request. Just let us know what exactly interests you. We will get back to you as soon as possible.

Your contact person

Sven J. Kolthof

CEO
Contact

Phone: +491714431139

Email: kolthof@arcoro.de

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    Your contact person

    Sven J. Kolthof

    CEO

    arcoro PROJECTS

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