arcoro Projects

Regulatory approval

Company

The customer is one of the leading international manufacturers of products for medical eye surgery. A special focus is on the area of ocular implants.

Competence area

  • Regulatory Affairs

Project tasks

  • Control of global RA management (CE (EU), 510(k) (US), PMA (US), CMDCAS, SOR92 (CAN), China, Taiwan, Japan, Australia, New Zealand, Latin America, Middle East, Russia, CIP states, BRIC states).
  • Reprocessing of technical documentation
  • Compatibility test along the standard ISO 10993-x
  • Control of CRO activities
  • Clinical evaluation according to MEDDEV 2.7.1

Project duration

  • 5 months

 

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Your contact person

Intsar Ahmad

Consultant MedTech & Pharma

Phone: 01703115127

Email: ahmad@arcoro.de

Field of expertise

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    Your contact person

    Intsar Ahmad

    Consultant MedTech & Pharma

    Phone: 01703115127

    Email: ahmad@arcoro.de