ISO 13485 Quality Management System

The CE marking of a medical device requires that the quality management system processes involved are compliant.
AGUILA supports you in the implementation of your ISO 13485 certification plan and helps you to design a simple, efficient and operational system.

Quality management system for medical devices

  • Initial audit - definition of the QMS implementation strategy
  • Assistance in the implementation of the QMS according to ISO13485 standard
  • Identification and implementation of quality processes

Qualification and validation

  • Creation of related documentation (quality manual, etc.)
  • Identification of particular processes (packaging, cleaning, sterilization, etc.)
  • Qualification / Validation of hardware and computerized systems
  • Support during audits

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ISO 13485

The International Standard ISO 13485 specifies the requirements for a quality management system where an organization must demonstrate its ability to regularly provide medical devices and associated services that conform to customer requirements and applicable standards requirements too.