jcktrue.dk/content/home/training.md

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accomplishments	true	45	Courses	2006-01-02	organization organization_url title url date_start date_end description Key2Compliance https://key2compliance.com/ Device Control Training /pdf/certificates/DesignControlTraining.pdf 2019-09-16 2019-09-17 Course content: - Introduction - Medical devices - EU - Combination products - Quality system strategy - Design Controls - Planning - User needs -> Design input - Risk management - Design Output - Design Review - Design Verification - Design Validation - Design Transfer - Design Changes - Design Documentation ”DHF” organization organization_url title url date_start date_end description Key2Compliance https://key2compliance.com/ Software development - regulatory requirements /pdf/certificates/SoftwareDevelopmentRegulatoryRequirements.pdf 2019-09-21 2019-09-23 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 organization_url title url date_start description medicaldeviceHQ https://medicaldevicehq.com/ Introduction to Risk Management for Medical Devices and ISO 14971:2019 /pdf/certificates/IntroductiontoRiskManagementforMedicalDevicesandISO14971_2019.pdf 2024-01-10 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 organization_url title url date_start description medicaldeviceHQ https://medicaldevicehq.com/ Risk Management for Medical Devices and ISO 14971:2019 https://www.credential.net/019bf8fb-3725-41d2-b267-38e19b22a71a?key=e4021d89e56370fd6995475c0ff5bdc123dddc83e100514801bd9ef480ebb0ba#gs.82vz01 2024-02-23 Blended classroom and online training. organization organization_url title url date_start description medicaldeviceHQ https://medicaldevicehq.com/ Introduction to Safety for Electrical Medical Devices and IEC 60601 https://www.credential.net/87beca3d-06af-4e2d-b023-364542df429a?key=dad188bb614ee747e23bf71c919d4437f6c951f17c667357a10568dbba6583c0#gs.82scio 2024-04-17 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.