Landing in Europe Medical Devices
What possible ways has a medical device company to land in Europe?
What possible ways has a medical device company to land in Europe?
Facilities and Quality Management
- Quality management system update according to ISO 13485 requirements.
- ISO 13485 Internal audit.
- Process risk management.
- Process validation.
Get the CE Mark Product
- Product classification.
- Elaboration of product Technical Documentation.
- Selection of notified body for CE mark , and product technical documentation submission.
- Selection of laboratories for testing.
Vigilance of the Market
- Development and implementation of the Post-Market Surveillance System.
- Management and notification of incidents.
- Post-market surveillance reports (PSUR)
- VIGILAZIERTA (Expert Vigilance Database)
What economic operators are defined in the MDR 2017/745 regulation in Europe?
What does it take to be a MANUFACTURER?
How can AZIERTA help you?
Azierta can guide you and accompany you through all the process, providing expert support in every step of the way.
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