New ISO standards for medical devices
Taking the headache out of regulations while improving product safety and performance.
Year of publication: 2016 | Edition: 1
A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.
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Related Standards
ISO 13485:2016
Medical devicesQuality management systemsRequirements for regulatory purposes- ISO 13485:2016 - Medical devices - A practical guideHandbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
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More information
ISO 13485 — Medical devices
Manage quality throughout the life cycle of a medical device with ISO 13485.
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