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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!

 

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ABOUT

services

MEDICAL DEVICES

It is estimate that the average general physician saves 4.7 lives per year; a medical writer can potentially save many more.

Quelle

PROJECTS WE WERE INVOLVED IN

Major Adboard

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.

 

More at

www.euhic.com.

Pre-Christmas Champagne

The recent multi-speaker educational forum in London examined training for medical writers. Success was ensured by pre-Christmas champagne and homemade mince pies

 

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