diff --git a/content/home/training.md b/content/home/training.md index c242938..2e19217 100644 --- a/content/home/training.md +++ b/content/home/training.md @@ -16,7 +16,6 @@ item: date_end: "2019-09-17" description: > Course content: - - Introduction - Medical devices - EU - Combination products - Quality system strategy @@ -24,13 +23,8 @@ item: - Planning - User needs -> Design input - Risk management - - Design Output - - Design Review - - Design Verification - - Design Validation - - Design Transfer - - Design Changes - - Design Documentation ”DHF” + - Design Output, Review, Verification, Validation, Transfer, Changes + - Design History File - organization: "Key2Compliance" organization_url: https://key2compliance.com/ @@ -40,14 +34,12 @@ item: date_end: "2019-09-23" description: > Course content: - - EU Medical Device Regulation + - EU Medical Device Regulation (MDR) - 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