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As such, your notified body may require you to conform to both standards, especially if you need to meet regulatory compliance in the EU. Comparatively, there are no major differences with ISO 13485:2016, except for the Z-Annexes. In 2012, as part of the harmonisation process with the European Union directives for the medical sector (93/42/EEC, 98/79/EC and 90/385/EEC), the EN ISO 13485: 2012 was released. Since then, it was revised twice in 20 respectively - with the latest being the 3rd edition ISO 13485:2016. The standard states the requirements of comprehensive quality management systems for the design and manufacture of medical devices products. The standard, officially known as the ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes, was first published by International Organization for Standardization (ISO) in 1996. Stendard Solution™ -generated documents include details that meet all the ISO 13485, US FDA 21 CFR Part 820, ISO 14971 and IEC 62304 requirements.
ISO 13485 2012.PDF SOFTWARE
In addition, medical device software (both standalone and embedded ones) are to comply with IEC 62304. The framework of this quality management system focuses on the need to handle risk management, in line with ISO 14971. Besides ISO 13485, US FDA 21 CFR Part 820 compliance is also mandatory for companies entering the United States market. This covers processes spanning the entire product life-cycle, including design and development, production, warehousing, distribution, installation and servicing activities. The ISO 13485: Quality Management System for Medical Devices is an international standard that was specifically published to define the requirements of a quality management system for organisations within the medical device industry.