Added IEC60601 course. (Including PDFs)
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@ -8,9 +8,10 @@ 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: "Key2Compliance"
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organization_url: https://key2compliance.com/
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title: "Device Control Training"
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url: /pdf/certificates/DesignControlTraining.pdf
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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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@ -31,9 +32,10 @@ item:
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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: "Key2Compliance"
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organization_url: https://key2compliance.com/
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title: "Software development - regulatory requirements"
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url: /pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf
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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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@ -55,12 +57,32 @@ item:
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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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title: "Introduction to Risk Management for Medical Devices and ISO 14971:2019"
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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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- 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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- 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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url: https://www.credential.net/019bf8fb-3725-41d2-b267-38e19b22a71a?key=e4021d89e56370fd6995475c0ff5bdc123dddc83e100514801bd9ef480ebb0ba#gs.82vz01
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date_start: "2024-02-23"
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description: Blended classroom and online training.
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- organization: "medicaldeviceHQ"
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organization_url: https://medicaldevicehq.com/
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title: "Introduction to Safety for Electrical Medical Devices and IEC 60601"
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url: https://www.credential.net/87beca3d-06af-4e2d-b023-364542df429a?key=dad188bb614ee747e23bf71c919d4437f6c951f17c667357a10568dbba6583c0#gs.82scio
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date_start: "2024-04-17"
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description: >
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Learning goals:
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- Understand what basic safety for a medical device is.
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- Understand why and how basic safety is implemented and the most common pitfalls in medical device product development and how to avoid them.
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- Strengthen your communication skills in the area of basic safety for medical devices.
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- Build awareness of effective management of safety throughout the product lifecycle.
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