Preparing for the Medical Device Regulation

An interactive webinar

On Friday the 3rd July 2020, 9:00 BST | 10:00 CEST , Dr Tina Amini, Medical Device Division Director, NDA Group will guide you through the key points to consider in your efforts to become Medical device regulation (MDR) compliant and focus on the implementation of MDR Article 117.

During this interactive seminar Tina 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. She will also highlight the impact to the manufacturers of integral drug-device combination products as the result of MDR and provide guidance on documentation to be submitted to the notified body.

Highlights:

  • 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)

To learn more about NDA’s Medical Device division and services click here


Click here to book your place today!


About the Speaker

Dr Tina Amini, a pharmacist with a PhD in Pharmaceutics, is Director of Medical Device Division at NDA Group.

She has over 30 years’ experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor.

Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry in a variety of disciplines.