General update. New address. syntax fixes here and there
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@ -13,13 +13,13 @@ content:
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email: jens.chr.true@gmail.com
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phone: +45 29 88 22 28
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address:
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street: Hasselgården 3
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city: Lemvig
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postcode: '7620'
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country: 'Denmark'
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street: Glentevej 5
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city: Struer
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postcode: 7600
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country: Denmark
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coordinates:
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latitude: '56.543939'
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longitude: '8.415900'
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latitude: '56.5106189'
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longitude: '8.5866002'
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contact_links:
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- icon: at
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icon_pack: fas
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@ -15,7 +15,7 @@ item:
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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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Course content:
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- Introduction
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- Medical devices - EU
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- Combination products
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@ -39,21 +39,21 @@ item:
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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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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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@ -61,7 +61,7 @@ item:
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url: /pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf
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date_start: "2024-01-10"
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description: >
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Learning goals:
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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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