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

 

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