![]() The interrelationships between ISO 13485:2016 and the associated European Directives / Regulations.The role of the Medical Devices Single Audit Program.How the principal changes defined in the new standard may be accommodated by an organisation that already has ISO 13485 certification and the transition timelines that apply.The structure of ISO 13485:2016 and how it interrelates with the Plan Do Check Act cycle.You want to learn about the latest ISO 13485 standard and have responsibility for managing the transition to your quality management system. 中国大陆 (中文) China Mainland (Simplified Chinese).中国台湾 (中文) Taiwan, China (Traditional Chinese). ![]()
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