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
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:
Requirements of other regulatory bodies in countries around the world Presentation will help you to:
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“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.
The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”
An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013