Gillian Pritchard

Contributions

Post-market clinical follow-up insights - Volume 31, Issue 2

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue 2

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

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…

Career opportunities in medical device writing: Employee and freelance perspectives - Volume 28, Issue 1

Many regulatory medical writers start their careers in pharma. Whilst many continue in pharma, some also work in medical devices and an increasing number are switching to medical device writing. This article explores how and why writers might move…

Medical Devices - Volume 27, Issue 4

The good news first: Patient-reported outcomes (PRO) are basically the same in both the medical device and the pharmaceutical sectors. There are the general quality of life tools such as the EQ-5D or the Short-Form Survey questionnaires (e.g. SF-12,…

Reports from the spring conference in Barcelona: 6th EMWA Symposium - Volume 27, Issue 3

We invited EMWA members to report on the medical device symposium and selected Expert Seminars during the spring conference in Barcelona, held in May 2018. We hope that this initiative will help to keep EMWA members up to date with our fast changing…

Clinical Evaluation Reports from the medical writer’s perspective! - Volume 26, Issue 2

Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…