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Let's Get you Ready for your Clinical Trial - EU perspective

Webinar with Marilyn Hendrickx, Clinical Program Manager, genae Belgium
​​​​​​​​​​​​​​28 March 2018

Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. The development of a successful device not only requires optimized design efforts, but also clinical, regulatory & marketing expertise.

View this 30 min. webinar to gain insight on the most important steps in designing your clinical trial from an EU perspective and increasing your chances of successfully launching your product.

Discussion points include:
•  Pre-development
•  Reimbursement Landscape
•  Regulatory Landscape
•  Concept formulation
•  Feasibility Assessment
•  Design: Verification & Validation
•  ISO13485: QMS
•  ISO14971: Risk Management
•  Clinical Evaluation
•  Clinical Investigation
•  Study Design
•  Study Conduct
•  Regulatory approval
•  Reimbursement application
•  Device launch preparation
•  Post Market Clinical Follow-up
•  Vigilance Reporting Requirements

Discover our other webinars:
•  Let's Get you Ready for your Clinical Trial - US perspective
•  Connect the dots of your clinical trial with staicy​​​​​​​
• ​​​​​​​ Are You Prepared For The New EU Medical Device Regulation?
​​​​​​​​​​​​​​• ​​​​​​​ Build your eCRF with ease using edc2go​​​​​​​
​​​​​​​​​​​​​​• ​​​​​​​ Easily manage & track image logistics with core lab tracker

How can we help you?

Want to hear more about our services or how we can support your clinical trial? Feel free to contact us with any questions you may have.

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