Quality and Risk-Management in the field of Ophthalmology
Company
The customer develops, produces and distributes instruments for ophthalmic surgery. The focus is on products used in cataract and vitreoretinal surgery.
Competence area
- Quality Management
Project tasks
- Monitoring of the clinical evaluation according to MEDDEV 2.7.1
- Control of a quality improvement project
- Implementation of ISO 13485 conformity
- Internal training and education on quality systematics
- ISO 10993 compatibility test for surgical instruments
- Development of risk documentation according to ISO 14971
Project duration
- 10 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