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ISO 13485:2016 for Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes

Kimberly A. Trautman, Executive Vice President, Medical Device International Services, Washington, DC, USA 

Keywords: Medical Devices Directive
Industry: Food/Drug/Cosmetic
Level: Intermediate


ISO 13485 is the international standard that defines quality management system requirements for organizations that are or may become involved in one or more stages of the medical device lifecycle. This includes design and development, production, storage and distribution, installation or servicing of a medical device, as well as design and development or provision of associated activities such as technical support. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services to such organizations. ISO 13485:2016 also provides an effective base model for regulatory compliance with: 

      • European Medical Devices Directive (MDD) 93/42/EEC
      • European In Vitro Medical Devices Diagnostic Directive (IVDD) 98/79/EC
      • Canadian Medical Devices Regulations SOR/98-282
      • Medical Device Single Audit Program (MDSAP)

Requirements of other regulatory bodies in countries around the world Presentation will help you to: 

      • Understand the design specifications for the 2016 version of ISO 13485 
      • Learn some of the differences between ISO 13485: 2003 and ISO 13485: 2016