Medical Devices

Elara Pharmaservices Europe with the support of our sister company Callisto Consulting can assist you in:

  • Medical device support internationally including the EU and US markets.
  • Preparation of technical files/design dossiers.
  • Preparation and review of essential requirements.
  • QMS management and training.
  • Audits to ISO13485.
  • Clinical evaluation reports and post-marketing clinical follow up.
  • Post-marketing surveillance.
  • Production and review of artwork text and mock-ups.
  • Ensure compliance with the Medical Devices Regulations (MDR).
  • Release of product under MDR by qualified personnel.

Extensive experience of human and veterinary medicines, medical devices, general products, herbal medicines, borderline products, food supplements and cosmetics.

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