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Our quality management system is based on an in-depth and comprehensive understanding of customers' expectations and the applicable regulatory requirements.
Compliance and regulations:
Each plant's quality management system is certified to ISO 13485 by a notified body (BSI or G-MED) and meets all the applicable regulations (FDA registration, ANVISA certification, etc.)
To guarantee a high level of compliance, preventive risk reduction and management actions are implemented throughout the production processes.
Process monitoring measures based on Validation & Verification activities guarantee that the product meets customers' expectations and requirements.
Support and services:
Changes in the global regulatory environment for medical devices are an opportunity for us to help our customers to draw up their required documentation and keep it up to date: lists of manufacturing process agents and contact materials, cleaning validation documents, strategy and protocols for validating processes and software, etc.