2019 - EU ISO 13485:2016 Medical Device Quality Management System

What are EU Notified-Body expectations under ISO 13485 and the MDR – with the recent major revisions to both?
How can a company develop and maintain a dual QMS.
Basic Systems / SOPs.
Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit.
Current areas of EU concern.
Maintaining compliance under increasing regulatory expectations.
Similarities and differences in the FDA and EU QMS’.