Executive Development Programme in Device Software Regulations
-- ViewingNowThe Executive Development Programme in Device Software Regulations is a crucial certificate course for professionals seeking expertise in the highly regulated medical device industry. This programme emphasizes the importance of compliance with software regulations, enabling learners to navigate the complex landscape and make informed decisions.
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⢠Introduction to Device Software Regulations
⢠Regulatory Bodies and their Roles in Device Software Regulations
⢠Understanding Software Life Cycle and its Regulations
⢠International Conference on Harmonisation (ICH) Guidelines
⢠Quality System Regulation (QSR) and Good Manufacturing Practices (GMP)
⢠Risk Management in Device Software Regulations
⢠EU Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR)
⢠US Food and Drug Administration (FDA) Regulations for Device Software
⢠Post-Market Surveillance and Reporting in Device Software Regulations
⢠Case Studies and Best Practices in Device Software Regulations
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