Kelly Goodwin Burri

Contributions

Editorial - Volume 31, Issue 2

Medical devices are at the core of healthcare forming a large share of the global healthcare market. With consistent advances in technology, MedTech is enhancing our lives more so now than a few decades ago owing to accelerated digitisation and…

Medical Devices - Volume 30, Issue 1

Hello, medical device fans! Social media is increasingly integrated into all aspects of our daily lives, even for many of you non-digital natives (myself included). In this issue, we look at how the medical device industry is beginning to utilise…

Medical Devices - Volume 29, Issue 4

The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…

Medical Devices - Volume 29, Issue 3

After the cancellation of EMWA’s Spring Conference this year, EMWA’s Medical Device Special Interest Group stepped up to ensure that members did not miss out on the Expert Seminar Series (ESS) by organising a virtual version of the event.

New documents required by the medical device regulation - Volume 29, Issue 3

This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…

Medical Devices - Volume 29, Issue 2

May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…

The value of registry data in the clinical evaluation of medical devices - Volume 29, Issue 2

Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…

Medical Devices - Volume 28, Issue 4

Digital health is touching many aspects of the medical device world. Here Beatrix Doerr provides her perspective on the ways digital health and artificial intelligence have touched the medical device world and have already changed the way healthcare…

Intelligent use of artificial intelligence for systematic reviews of medical devices - Volume 28, Issue 4

Systematic literature reviews are an essential component of the medical device clinical evaluation process. The EU Medical Device Regulation requirement for regularly updated systematic literature searches will increase the burden on the medical…

Medical Devices - Volume 28, Issue 3

Medical devices should certainly be included on any list of trends in medical writing. That impression was only reinforced by the strong interest in device writing evident at this year’s EMWA spring conference. The three medical device workshops on…