This training in Clinical Evaluation Reporting is built upon theory and real life cases:
1) We will review together the MEDDEV and MDR requirement on how to document clinical evidence.
2) The participants are invited to send up front, product examples to the trainer and the workshops will be built on these.
3) Participants will get time to 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.
The workshop will take place on 30 October, 2019, In Tel Aviv metropolitan area. An excat location will be provided later.
The number of seats is limited!
* The workshop will be held in English.
* For registration by phone, please contact us on Sundays through Thursdays between 8:30-15:30.
* Cancellation until 15/9/19 - full refund. *Cancellation until 01/10/19 - 50% refund. *After this - full payment.
The workshop will be held byHelene 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.