
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…
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…
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…
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…
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…
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…
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…