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ISO 13485 ensures that medical devices meet the needs of the costumers, and fulfill regulatory requirements.
This standard was conceived to help medical device manufacturers to implement Quality Management Systems that establish and maintain the effectiveness of their process. It ensures the consistent design, development, production, installation and delivery of medical devices safe for their intended purpose.
This standard represents the need for a risk-based approach to the Quality Management System and enhances the approach to regulatory requirements and top management responsibilities, improved supplier controls and external activities. It makes an emphasis on risk management throughout the product life cycle.