[Expert Solution]: (25 points) (a) Give the full names of the…

Question 1 (25 points) (a) Give the full names of the organisations designated as (i) the competent authority and (ii) the notified body for medical device regulation in Ireland. [4] (b) List two new regulations and two new features in the European Medical Device Regulation (MDR EU 2017/745). [4] (c) Briefly state the differences between carrying out a conformity assessment in accordance with MDR Annex IX and Annex XI. [5] (d) Briefly explain the concept of substantial equivalence in relation to the FDA’s 510(k) process. [5] (e) A computational model has been developed to determine the load required to induce yielding in the femoral stem of a hip prosthesis. i. What are the two important factors to consider in determining model risk, in accordance with the V&V40? [3] ii. State two verification activities and two validation activities recommended by the V&V40 that could be undertaken to increase model credibility. [4]