8:00 a.m. – 8:30 a.m. |
Registration/Continental Breakfast |
8:30 a.m. – 9:30 a.m. |
Part A – The Internal Quality Audit Program
|
9:30 a.m. – 10:15 a.m. |
Part B – EU-MDR/IVDR Conformity Assessment Paths
|
10:15 a.m. – 10:30 a.m. |
Morning Break |
10:30 a.m. – 11:15 a.m. |
Part C – EU-MDR/IVDR QMS & RMS Considerations
|
11:15 a.m. – 12:00 p.m. |
Part D – Preparing the Application to the NB
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 2:15 p.m. |
Part E – The NB Approach
|
2:15 p.m. – 2:30 p.m. |
Afternoon Break |
2:30 p.m. – 4:00 p.m. |
Part F – Mapping the NB Approach to the Audit Program
|
4:00 p.m. |
Workshop Completed |
Description of the Exercises
Course 3 - Implementing Effective EU-MDR/IVDR Internal Audit Programs
Exercise B1 – Selecting a Conformity Assessment Path
Participants review the available conformity assessment paths for a device and determine the best fit.
Exercise C1 – Identify and Resolve Gaps from ISO 13485:2016
Participants review gaps between EU-MDR or the EU-IVDR conformity assessment paths and ISO 13485:2016 and identify specific actions to close the QMS gap.
Exercise E1 – Review Specific NB Audit Areas and Develop Plans
Participants review the NB requirements from Annex VII, determine gaps in the QMS, and identify specific actions to close the gap.
Exercise F1 – Map the NB Audit to the Internal Audit Program
Participants determine needed EU-MDR or EU-IVDR audits and locate them in the internal audit program.
Exercise F2 – Report to Management Review
Participants develop a report for management review on the EU-MDR or EU-IVDR and the readiness for successful implementation.
Course I | Course II | Course III