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This primer will explore updates and priorities in the application of incorporating digital health software requirements into the quality management system to support the development of connected combination products. ISO 14971:2019 and its impact to the current quality management system requirements under EU MDR Article 10 and 21 CFR Part 4 will be presented and discussed during the session. A discussion on the recent ISO/TR 24971:2020 guidance and the application to ISO 14971:2019 will be emphasized including the overall impact to digital health and combination products.
- Identify key software application and digital health requirements to incorporate into the quality management system for combination products
- Analyze the impact of ISO 14971:2019 and ISO TR 24971:2020 to the combination product quality management system
- Define the key requirements of EU MDR Article 10 and the impact to Article 117 products