MDCG 2020 Guidance on significant changes- Review, problems and tips Automatically Convert Oracle Forms Code to Delphi Code MDR- Significant changes in the design and intended purpose Lesson 2 - convert a real application (Oracle Form => Delphi) Lesson1-How to migrate your Forms code and build HTM5 APP Windows xp/7 - What can we do ? Bi-dimensional risk analysis - safety&security -software medical device Clinical investigations - Intended Normal condition of use Review Mdcg 2019-11 guidance on qualification and classification of software mdcg 2019 11 Decision steps for qualification of software as MDSW Mdcg 2019 11 guidance on qualification and classification of software mdr-ivdr Rule 11 and imdrf ue 2017 745 v06 Rule 11 vs Rule 10 UE 2017-745 v01 EU 2017/745 Rule 11 (re)interpretation