jcktrue.dk/content/home/training.md

widget	headless	weight	title	date_format	item
accomplishments	true	45	Courses	2006-01-02	organization organization_url title date_start date_end description KEY2COMPLIANCE AB https://key2compliance.com/ Device Control Training 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 date_start date_end description KEY2COMPLIANCE AB https://key2compliance.com/ Software development - regulatory requirements 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 date_start description medicaldeviceHQ https://medicaldevicehq.com/ Risk Management for Medical Devices and ISO 14971:2019 2024-02-23 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.