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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Your contact person
Samuel Mesfin
Business Enablement Manager
Phone: 01717675483
Email: mesfin@arcoro.de
Field of expertise
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Your contact person
Samuel Mesfin
Business Enablement Manager
Phone: 01717675483
Email: mesfin@arcoro.de