Application of risk management for IT-networks incorporating medical devices Guidance the disclosure and communication device security needs, risks controls
€374.00
Application of risk management for IT-networks incorporating medical devices Guidance wireless networks
Medical devices. Guidance on the application of ISO 14971
€269.00
BS EN 60601-2-23. Medical electrical equipment Part 2-23. Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring
€23.00
Health software and health IT systems safety, effectiveness security Security. Activities in the product life cycle
Medical devices. Symbols to be used with information supplied by the manufacturer General requirements
€355.00
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
€21.00
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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Medical devices - Application of risk management to medical devices (ISO 14971:2019)
€58.00
€166.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
€208.00
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
€187.00
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
€89.00
