ISO 13485 - Quality management for medical devices
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.
ISO 13485 - Quality management for medical devices
ISO 13485 - Quality management for medical devices
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Related Standards
- Medical devices — Quality management systems — Requirements for regulatory purposes
- Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
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Bundle - 10% discount
Medical devices - the basics
This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.
- ISO 13485:2016
- ISO 13485:2016 A practical guide
- ISO 14971:2019
- ISO/TR 24971:2020
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More information
Manage quality throughout the life cycle of a medical device with ISO 13485.