Clinical Evaluation Reporting (CER) workshop

This training in Clinical Evaluation Reporting is built upon theory and real life cases:
- We will review together the MEDDEV and MDR requirement on how to document clinical evidence.
- The participants are invited to send up front, product examples to the trainer and the workshops will be built on these.
- Participants will get time during the workshops to work directly with their own product case with the guidance from your trainer.

By attending this workshop you will be able to:
1) Set up a literature search strategy, conduct basic literature and train on different appraisal techniques.
2) Search for available post market clinical data.
3) Put together a clinical evaluation report (CER).
4) Understand Usability test and Clinical Investigation set up and the differences.

Agenda:

The workshop will take place on 30 October, 2019, at REGUS, Ariel Sharon St. 8, Or Yehuda.

The workshop will be held by Helene QUIE:
CEO of QMED Consulting. Helene Quie has a degree in Science specialised within cell-biology from the University of Odense. Helene has 20 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S. Her primary expertise is within the clinical and regulatory areas of medical devices such as:
1. Device development
2. Quality & Project management
3. Clinical trial execution & Clinical Evaluation
4. Market access and general management.