Thought Leadership

At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.

We call it Thought Leadership.

Articles and White Papers

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18-03-2021

NDA Webinars Medical Device Regulation: Session 5

In the fifth session in our MDR seminar series, Dr Tina Amini walks you through the Post Market Surveillance (PMS) requirements under the EU MDR
09-03-2021

NDA Webinars Medical Device Regulation: Session 4

In the fourth session in our MDR seminar series, Dr Tina Amini walks you through the clinical evaluation of Medical Devices.
19-02-2021

NDA Webinars Medical Device Regulation: Session 3

In the third session in our MDR seminar series, Dr Tina Amini walks you through the details of the impact of EU MDR on Drug/Device Combination Products (DDCs).
05-02-2021

NDA Webinars Medical Device Regulation: Session 2

In the second session in our MDR seminar series, Dr Tina Amini walks you through the details of the MDR requirements when it comes to QMS and the necessary steps to ensure compliance with MDR requirements.
28-01-2021

NDA Webinars Medical Device Regulation: Session 1

In the first session of our webinar series Dr Tina Amini, Medical Device Division Director at NDA presents an introduction to MDR and the key changes
02-04-2020

New EU In vitro Diagnostics Regulation (IVDR) and Companion Diagnostics

The companion diagnostics market is an emerging market and is anticipated to experience significant growth owing to increase in targeted therapies, rise in demand for personalised medicine with increase in awareness in emerging economies, discovery of n...