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@@ -16,7 +16,6 @@ item:
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date_end: "2019-09-17"
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description: >
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Course content:
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- Introduction
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- Medical devices - EU
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- Combination products
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- Quality system strategy
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@@ -24,13 +23,8 @@ item:
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- Planning
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- User needs -> Design input
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- Risk management
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- Design Output
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- Design Review
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- Design Verification
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- Design Validation
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- Design Transfer
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- Design Changes
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- Design Documentation ”DHF”
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- Design Output, Review, Verification, Validation, Transfer, Changes
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- Design History File
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- organization: "Key2Compliance"
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organization_url: https://key2compliance.com/
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@@ -40,14 +34,12 @@ item:
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date_end: "2019-09-23"
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description: >
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Course content:
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- EU Medical Device Regulation
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- EU Medical Device Regulation (MDR)
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- FDA regulations
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- Good practice: SW lifecycle processes
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- 60601 with focus on chapter 14, contribution of SW to essential performance
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- 62304 - Software development lifecycle
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- Development For class C software
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- Short intro to risk management - ISO 14971
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- Software safety class
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- Software risk in relation to 62304
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- Concept cybersecurity
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- Cybersecurity risk management process
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