Quality and Risk-Management in the field of Ophthalmology


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

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


Phone: +491714431139


    *Requiered fields
    Your contact person

    Sven J. Kolthof


    arcoro PROJECTS

    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