Home ISO ISO 13485:2012 Quality Management System for Medical Devices

ISO 13485:2012 Quality Management System for Medical Devices

January 3, 2019

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ISO 13485:2012 Quality Management System for Medical Devices

ISO 13485 specifies all the requirements for a quality management system which an organization needs to demonstrate its ability in medical devices and connected services that without fail meet the customer requirements and regulatory requirements. The primary objective of ISO 13485 is to facilitate and harmonize medical device regulatory requirements for quality management systems. This controls the work environment and ensures product safety. Further, it also focuses on risk management activities and design transfer activities during product development. In addition to this it specific requirements for documentation and validation of processes for sterile medical devices. Aapka Consultant understands all these issues and can perform the necessary assessment/Improvement to help you achieve ISO 13485:2012 Certification.

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