Medical devices are a fascinating area. We are constantly amazed at the ingenuity of developers. Our team is fortunate to have worked with a variety companies, universities and clever physicians. We have also written and taught about medical device writing.
Projects involving the larger companies are usually well structured and led by a diverse team. They are usually clear in what they require. By comparison, pioneering physicians and small organisation often need more support and here we can make a real difference.
Patient safety is increasingly a focus requiring new and more detailed documentation. New guidelines include the European Medical Devices Regulation (MDR) 2017/745, In Vitro Diagnostic Regulation (IVDR) 2017/746 and MEDDEV 2.7/1 Rev4: Clinical Evaluation Guidelines. Updates to ISO14155:2011: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, will likely add further to the regulatory burden. And then, of course, there are edicts of national competent authorities e.g. MHRA. An increasingly complicated landscape!
It is estimate that the average general physician saves 4.7 lives per year; a medical writer can potentially save many more.
PROJECTS WE WERE INVOLVED IN
We are currently working with a global client to deliver a major Adboard around dietary supplements in pregnancy.
EuHic Conferences 2019
Two further meetings are planned for London and Berlin in 2019.
The recent multi-speaker educational forum in London examined training for medical writers. Success was ensured by pre-Christmas champagne and homemade mince pies