Day2

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

  • ISO 13485:2016 audit requirements
  • Planning internal audits
  • Conducting internal audits
  • Reporting internal audits
  • Resolving audit nonconformances

9:30 a.m. – 10:15 a.m.

Part B – EU-MDR/IVDR Conformity Assessment Paths

  • Annex VIII classification
  • Options for EU-MDR Devices
  • Options for EU-IVDR Devices
  • Exercise B1 – Selecting a Conformity Assessment Path

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

  • Understanding Article 10
  • Understanding CEN/TR 17223:2018
  • Understanding ISO 13485:2016
  • Understanding ISO 14971:2019
  • Developing the Annex II and Annex III documentation
  • Exercise C1 – Identify and Resolve Gaps from ISO 13485:2016

11:15 a.m. – 12:00 p.m.

Part D – Preparing the Application to the NB

  • EU-MDR applications
  • EU-IVDR applications

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:15 p.m.

Part E – The NB Approach

  • The NB QMS requirements
  • Specific NB audit areas
  • Specific NB competence requirements
  • EU-MDR Article 106 Expert Panels
  • EU-IVDR Article 100 Reference Laboratories
  • Exercise E1 – Review Specific NB Audit Areas and Develop Plans

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

  • Specific audits
  • Specific internal auditor competence
  • Resolving audit nonconformances
  • Management review
  • Exercise F1 – Map the NB Audit to the Internal Audit Program
  • Exercise F2 – Report to Management Review

4:00 p.m.

Workshop Completed

 

register

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

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