Programme

Clinical Evaluation of Medical Devices 6 th – 8 th November 2017

Tuesday 7 th November 2017

09.00 – 10.00

Lecture 3: Who should perform the Clinical Evaluation?

Rachel Hattersley Dykes CROMSOURCE

10.00 – 11.00

Lecture 4: Regulatory Control of Clinical Investigations • Types of Clinical Studies • ISO14155 • Implication of MDR Clinical Strategy Notification Requirements. The role of the Clinical Team and Regulatory Governance Lecture 5: Regulatory Control of Clinical Investigations • Clinical evaluations • Clinical investigations • Post-market clinical obligations and studies Refreshment Break

Angela Stokes INC Research

11.00 – 11.30 11.30 – 12.30

Angela Stokes INC Research

12.30 – 13.30 13.30 – 15.00

Lunch

Lecture 6: The place of Clinical Evaluation within Device Life-cycle and technical documentation

Gillian Seaton NAMSA

14.00 - 15.30

Lecture 7: The Equivalence Assessment, cornerstone of clinical evaluations for medical devices

Edith Millan NAMSA

15.30 – 16.00 16.00 – 17.15

Refreshment Break

Lecture8: Clinical Global Strategy Requirements – focus on US FDA specifics

Sharon Herbert NAMSA (webex)

17.15 – 18.30

Case study

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