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ICS:11.040.01
Showing 1–9 of 31 results
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ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
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ISO 14971:2019 Medical devices – Application of risk management to medical devices
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ISO 15223:2010 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validation
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ISO 15223:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
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ISO 15223:2025 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements – Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
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ISO 15378:2017 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
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ISO 15378:2024 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) – Amendment 1: Climate action changes
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ISO 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 – Devices for administration of medicinal products and catheters
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ISO 20069:2019 Guidance for assessment and evaluation of changes to drug delivery systems
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