diff --git a/content/home/training.md b/content/home/training.md index a4d5c7e..b03c1a2 100644 --- a/content/home/training.md +++ b/content/home/training.md @@ -8,9 +8,10 @@ title: "Courses" date_format: "2006-01-02" item: -- organization: "KEY2COMPLIANCE AB" +- organization: "Key2Compliance" organization_url: https://key2compliance.com/ title: "Device Control Training" + url: /pdf/certificates/DesignControlTraining.pdf date_start: "2019-09-16" date_end: "2019-09-17" description: > @@ -31,9 +32,10 @@ item: - Design Changes - Design Documentation ”DHF” -- organization: "KEY2COMPLIANCE AB" +- organization: "Key2Compliance" organization_url: https://key2compliance.com/ title: "Software development - regulatory requirements" + url: /pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf date_start: "2019-09-21" date_end: "2019-09-23" description: > @@ -55,12 +57,32 @@ item: - organization: "medicaldeviceHQ" organization_url: https://medicaldevicehq.com/ - title: "Risk Management for Medical Devices and ISO 14971:2019" - date_start: "2024-02-23" + title: "Introduction to Risk Management for Medical Devices and ISO 14971:2019" + url: /pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf + date_start: "2024-01-10" description: > 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. +- organization: "medicaldeviceHQ" + organization_url: https://medicaldevicehq.com/ + title: "Risk Management for Medical Devices and ISO 14971:2019" + url: https://www.credential.net/019bf8fb-3725-41d2-b267-38e19b22a71a?key=e4021d89e56370fd6995475c0ff5bdc123dddc83e100514801bd9ef480ebb0ba#gs.82vz01 + date_start: "2024-02-23" + description: Blended classroom and online training. + +- organization: "medicaldeviceHQ" + organization_url: https://medicaldevicehq.com/ + title: "Introduction to Safety for Electrical Medical Devices and IEC 60601" + url: https://www.credential.net/87beca3d-06af-4e2d-b023-364542df429a?key=dad188bb614ee747e23bf71c919d4437f6c951f17c667357a10568dbba6583c0#gs.82scio + date_start: "2024-04-17" + description: > + Learning goals: + - Understand what basic safety for a medical device is. + - Understand why and how basic safety is implemented and the most common pitfalls in medical device product development and how to avoid them. + - Strengthen your communication skills in the area of basic safety for medical devices. + - Build awareness of effective management of safety throughout the product lifecycle. + --- \ No newline at end of file diff --git a/static/pdf/certificates/DesignControlTraining.pdf b/static/pdf/certificates/DesignControlTraining.pdf new file mode 100644 index 0000000..c2ad00c Binary files /dev/null and b/static/pdf/certificates/DesignControlTraining.pdf differ diff --git a/static/pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf b/static/pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf new file mode 100644 index 0000000..e2272b1 Binary files /dev/null and b/static/pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf differ diff --git a/static/pdf/certificates/IntroductiontoSafetyforElectricalMedicalDevicesandIEC60601.pdf b/static/pdf/certificates/IntroductiontoSafetyforElectricalMedicalDevicesandIEC60601.pdf new file mode 100644 index 0000000..bcc38e4 Binary files /dev/null and b/static/pdf/certificates/IntroductiontoSafetyforElectricalMedicalDevicesandIEC60601.pdf differ diff --git a/static/pdf/certificates/RiskManagementforMedicalDevicesandISO14971_2019.pdf b/static/pdf/certificates/RiskManagementforMedicalDevicesandISO14971_2019.pdf new file mode 100644 index 0000000..159ab52 Binary files /dev/null and b/static/pdf/certificates/RiskManagementforMedicalDevicesandISO14971_2019.pdf differ diff --git a/static/pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf b/static/pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf new file mode 100644 index 0000000..5cabdab Binary files /dev/null and b/static/pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf differ