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General update. New address. syntax fixes here and there
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This commit is contained in:
2025-02-27 13:43:08 +00:00
parent bc3b15a0e8
commit 1362e97b37
5 changed files with 45 additions and 29 deletions

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@ -13,13 +13,13 @@ content:
email: jens.chr.true@gmail.com
phone: +45 29 88 22 28
address:
street: Hasselgården 3
city: Lemvig
postcode: '7620'
country: 'Denmark'
street: Glentevej 5
city: Struer
postcode: 7600
country: Denmark
coordinates:
latitude: '56.543939'
longitude: '8.415900'
latitude: '56.5106189'
longitude: '8.5866002'
contact_links:
- icon: at
icon_pack: fas

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@ -15,7 +15,7 @@ item:
date_start: "2019-09-16"
date_end: "2019-09-17"
description: >
Course content:
Course content:
- Introduction
- Medical devices - EU
- Combination products
@ -39,21 +39,21 @@ item:
date_start: "2019-09-21"
date_end: "2019-09-23"
description: >
Course content:
- EU Medical Device Regulation
- FDA regulations
- Good practice: SW lifecycle processes
- 60601 with focus on chapter 14, contribution of SW to essential performance
- 62304 - Software development lifecycle
- Development For class C software
- Short intro to risk management - ISO 14971
- Software safety class
- Software risk in relation to 62304
- Concept cybersecurity
- Cybersecurity risk management process
- Agile SW development
- GDPR/HIPAA
- Tool validation
Course content:
- EU Medical Device Regulation
- FDA regulations
- Good practice: SW lifecycle processes
- 60601 with focus on chapter 14, contribution of SW to essential performance
- 62304 - Software development lifecycle
- Development For class C software
- Short intro to risk management - ISO 14971
- Software safety class
- Software risk in relation to 62304
- Concept cybersecurity
- Cybersecurity risk management process
- Agile SW development
- GDPR/HIPAA
- Tool validation
- organization: "medicaldeviceHQ"
organization_url: https://medicaldevicehq.com/
@ -61,7 +61,7 @@ item:
url: /pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf
date_start: "2024-01-10"
description: >
Learning goals:
Learning goals:
- To understand the overall process of risk management and how to create safe medical devices.
- To strengthen the ability of participants to independently perform risk analysis, risk evaluation and risk control.
- To establish and increase knowledge on risk management tools and their differences, such as FMEA and P-FMEA.