What possible ways has a medical device company to land in Europe?
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Quality management system update according to ISO 13485 requirements.
ISO 13485 Internal audit.
Process risk management.
Process validation.
Suppliers’ audits.
Product classification.
Elaboration of product Technical Documentation.
Selection of notified body for CE mark , and product technical documentation submission.
Selection of laboratories for testing.
Communication of placing in 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?
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Azierta can guide you and accompany you through all the process, providing expert support in every step of the way.
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