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2025-10-30 20:43:34 +01:00
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@@ -16,7 +16,6 @@ item:
date_end: "2019-09-17" date_end: "2019-09-17"
description: > description: >
Course content: Course content:
- Introduction
- Medical devices - EU - Medical devices - EU
- Combination products - Combination products
- Quality system strategy - Quality system strategy
@@ -24,13 +23,8 @@ item:
- Planning - Planning
- User needs -> Design input - User needs -> Design input
- Risk management - Risk management
- Design Output - Design Output, Review, Verification, Validation, Transfer, Changes
- Design Review - Design History File
- Design Verification
- Design Validation
- Design Transfer
- Design Changes
- Design Documentation ”DHF”
- organization: "Key2Compliance" - organization: "Key2Compliance"
organization_url: https://key2compliance.com/ organization_url: https://key2compliance.com/
@@ -40,14 +34,12 @@ item:
date_end: "2019-09-23" date_end: "2019-09-23"
description: > description: >
Course content: Course content:
- EU Medical Device Regulation - EU Medical Device Regulation (MDR)
- FDA regulations - FDA regulations
- Good practice: SW lifecycle processes - Good practice: SW lifecycle processes
- 60601 with focus on chapter 14, contribution of SW to essential performance - 60601 with focus on chapter 14, contribution of SW to essential performance
- 62304 - Software development lifecycle - 62304 - Software development lifecycle
- Development For class C software - Development For class C software
- Short intro to risk management - ISO 14971
- Software safety class
- Software risk in relation to 62304 - Software risk in relation to 62304
- Concept cybersecurity - Concept cybersecurity
- Cybersecurity risk management process - Cybersecurity risk management process