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.