9 Steps to right first time regulatory compliance
July 17 2018
It can be a scary thought, regulatory compliance. So much to get your head around, so much to make sure is done right, and what…
Archive
15 things you need to know about MHRA Human Factors expectations
September 21 2017
We now have official guidance for Human Factors and Usability Engineering in a member state of the EU. 19th September 2017 saw publication of official…
Navigating the transition
September 5 2017
The countdown clock to the application of new EU Medical Device Regulation (MDR) started its three year life in May 2017. Understanding the changes, let…
Human Factors high on FDA Priorities for 2016
January 20 2016
So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have…
MHRA developing human factors guidance for medical devices
December 10 2015
UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started to develop guidance on human factors for medical devices. We are curious…
Correct these 9 deficiencies to avoid becoming regulatory inspection road-kill
February 18 2015
It’s not unusual to be thinking about how regulators will see your product development and where they may find holes. The closer you get to…