The customer develops, produces and distributes instruments for ophthalmic surgery. The focus is on products used in cataract and vitreoretinal surgery.
- Quality Management
- 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
- 10 months
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Quality management system optimization and workshops
Segment: surgical equipment and instruments
Project management global MDR
Segment: ophthalmic and medical devices
Project management for quality assurance and process verification
Segment: Prosthetics and Wearable Bionics