TNI - Technical standards information - Slovak standards

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

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Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

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Medical devices. Guidance on the application of ISO 14971 (ISO/TR 24971: 2020)

Available languages: Slovak

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Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

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Medical devices. Post-market surveillance for manufacturers

Available languages: Slovak

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Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

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Medical gloves for single use - Guidance for selection

Available languages: English

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Dentistry - Guidance on the classification of dental devices and accessories

Available languages: English

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Dentistry - Guidance on the classification of dental devices and accessories

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Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory

Available languages: English

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