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.