A patient sending mail, a scientist sending literature, a company sending data and a doctor sending blood samples or laboratory results to a company, symbolizing clinical evaluation according to MEDDEV

Clinical Evaluation of Medical Devices

Workshop on September 23, 2019 in Frankfurt

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MEDDEV guidelines are helpful

Manufacturers must carry out a clinical evaluation before they can place medical devices on the European market. The guideline MEDDEV 2.7/1 Rev. 4, published in 2016, explains how a clinical evaluation of a medical device is to be prepared. It partly anticipates the requirements of the new Medical Device Regulation (MDR).

Medical device manufacturers face major challenges when carrying out a clinical evaluation with respect to the content and scientific implementation as well to the translation of the requirements into the quality management system.

Benefit From Practical Experience

Our experts are experienced in conducting clinical evaluations for all medical device risk classes. In this practice-oriented workshop, they will discuss with you in particular the practical experience gained in implementing the guideline as well as the new MDR requirements.

A maximum of 50 participants are admitted in order to provide sufficient opportunities for discussion and direct contact with our experts. Register today!

Program

Workshop language will be German. A German program is available, too.

13:30Registration
14:00Welcome and Introduction
Dr. Thorsten Prinz
Senior Manager. VDE Medical Software
14:15How do I conduct a Clinical Evaluation?
Prof. Dr. med. Michael Imhoff
Medical Faculty, Ruhr University Bochum, Medical Director, qtec group, Lübeck
Key questions and discussion:
– What is a clinical evaluation?
– What are the requirements for a clinical evaluation?
– How should the risk-benefit analysis be carried out?
– How can an equivalence analysis be performed?
15:00Clinical Evaluation from the Point of View of the Manufacturer: What does the Clinical Evaluation require of the Development Process?
Dr. Jens-Uwe Hagenah
Senior Manager Clinical Affairs, Drägerwerk AG & Co. KGaA, Lübeck, Germany
Key questions and discussion:
– How does the clinical evaluation work in the life cycle of the product and how does it impact the development process?
– What is the relationship between clinical evaluation and risk management?
– How are the clinical requirements implemented in the design of the product?
– How do laboratory data, literature data and clinical trial data interact?
– Which internal supplements of the manufacturer and interpretations of MEDDEV and MDR are possible for non-implantable products?
15:45Coffee Break
16:15Where to get if not stealing it? – How do I generate Clinical Data for Clinical Evaluations?
Prof. Dr. med. Michael Imhoff
Key questions and discussion:
– What are clinical data?
– Why does it (also) make sense to be a study sponsor?
– How do I conduct PMCF studies?
– What do Investigator Initiated Trials (IIT) and off-label use mean?
– What are the alternatives to clinical data?
17:00Discussion
17:30End of Event

Program is subject to change without notice. Last updated: May 2019

Venue

VDE
Room “Ohm” (Ground Floor, V.00.024)
Stresemannallee 15
(Access via: Schreyerstraße)
60596 Frankfurt am Main

Participation

The participation fee is 150 EUR for non-members and 135 EUR for VDE members. Participation and refreshments during breaks are included, but not the cost of overnight accommodation or travel to and from the event. Cancellation conditions: free of charge up to 14 days before the date of the event, thereafter 100 percent of the participation fee as cancellation fee. The number of participants is limited to 50. The event will take place with a minimum of 15 participants. If the minimum number of participants is not reached the organizer reserves the right to cancel any booking on short notice. In this case all payed fees will be refunded. The organizer reserves the right to program changes without prior notice.
Photos are taken for media coverage on various platforms. If you do not want to be photographed, please let the staff present know.

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