Webinar: Preparing for the Medical Device regulation

NDA Group would like to invite you to an online seminar

Date: 3rd July 2020
Time: 10 AM CET – 11 AM CET: presentation and general Q &A
Where: Digital via Zoom
Register Now: https://mailchi.mp/757a660fbb94/preparing-for-the-medical-device-regulation-virtual-seminar-572686

This seminar will discuss integrated product development for Medical Device Regulation.
Our presenters will clarify the requirements applicable to medical devices under the new Regulation, highlight the major changes and provide an understanding of the impact on the industry. Impact to the manufacturers of integral drug-device combination products as the result of MDR will be discussed with guidance on documentation to be submitted to notified body.

Learning aspects:

• Understanding the new regulatory requirements under MDR
• MDR Article 117
• Notified Body expectations for Device aspect of Combination products Drug/Device (regulated as medicinal products) or Device/Drug (regulated a medical device)

Our speakers for the day:

• Stephanie Krumholz, General Manager, NDA Switzerland
• Tina Amini, Medical Device Division Director, NDA Group