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Software as a Medical Device
EU Medical Devices Regulation
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Validation
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10 May 2019
26 June 2025
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Economic Operators Gap Assessment
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Economic Operators Gap Assessment
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10 May 2019
26 June 2025
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Failure Mode and Effect Analysis
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Failure Mode and Effect Analysis
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22 April 2018
26 June 2025
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Gap Analysis Report Template
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Gap Analysis Report Template
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27 June 2015
26 June 2025
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Guidance for EU MDR – Systems and Procedure Packs
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Guidance for EU MDR – Systems and Procedure Packs
admin
14 May 2019
26 June 2025
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Guidance for EU MDR 2017/745 – Reusable Medical Devices (Class Ir)
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Guidance for EU MDR 2017/745 – Reusable Medical Devices (Class Ir)
admin
11 December 2019
26 June 2025
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Guidance for EU MDR 2017/745 – Drug-Device combination products
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Guidance for EU MDR 2017/745 – Drug-Device combination products
admin
10 November 2019
26 June 2025
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Guidance for EU MDR Software as a Medical Device (SaMD)
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Guidance for EU MDR Software as a Medical Device (SaMD)
admin
13 May 2019
26 June 2025
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Guidance for Unique Device Identifier (UDI)
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Guidance for Unique Device Identifier (UDI)
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10 May 2019
26 June 2025
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IOQ for Anaerobic Cabinet
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IOQ for Anaerobic Cabinet
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24 April 2018
26 June 2025
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IOQ for Incubator
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IOQ for Incubator
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26 June 2025
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MDR Complete Package
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MDR Complete Package
admin
13 May 2019
26 June 2025
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Periodic Survey Update Template
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Periodic Survey Update Template
admin
10 May 2019
26 June 2025
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