Jens True
fa3961713b
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67 lines
2.0 KiB
Markdown
67 lines
2.0 KiB
Markdown
---
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widget: "accomplishments"
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headless: true
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weight: 45
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title: "Courses"
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date_format: "2006-01-02"
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item:
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- organization: "KEY2COMPLIANCE AB"
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organization_url: https://key2compliance.com/
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title: "Device Control Training"
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date_start: "2019-09-16"
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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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- Design Controls
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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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- organization: "KEY2COMPLIANCE AB"
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organization_url: https://key2compliance.com/
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title: "Software development - regulatory requirements"
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date_start: "2019-09-21"
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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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- 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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- Agile SW development
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- GDPR/HIPAA
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- Tool validation
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- organization: "medicaldeviceHQ"
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organization_url: https://medicaldevicehq.com/
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title: "Risk Management for Medical Devices and ISO 14971:2019"
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date_start: "2024-02-23"
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description: >
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Learning goals:
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- To understand the overall process of risk management and how to create safe medical devices.
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- To strengthen the ability of participants to independently perform risk analysis, risk evaluation and risk control.
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- To establish and increase knowledge on risk management tools and their differences, such as FMEA and P-FMEA.
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--- |