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!