arcoro PROJECTS

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

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

Ana Aleksova

Business Manager MedTech
Contact

Phone: +4915115623724

Email: aleksova@arcoro.de

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    Your contact person

    Ana Aleksova

    Business Manager MedTech

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