25th January 2019
By Mike Heald, Commala Ltd., (Medilink WM member). Beginning near the middle, by explaining when not to start risk management, this series of eight articles looks at some of the practical aspects of actually doing risk management, before ending at the beginning; the fundamental need for risk management.
19th September 2018
By Medilink member, Three Circles. Medical devices, and combination products, are typically targeted at therapeutic areas with large patient populations, so recruitment is fairly straightforward …
6th September 2018
A potential silver lining for medical device developers and manufacturers exists in the FDA’s response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.
8th August 2018
There’s an often overlooked aspect of getting a medical device into the healthcare system (e.g. the NHS in the UK). Recognition of the importance of involving patients and public in healthcare has implications for the development of medical devices and combination products.