4 W’s of Design Review

Developing a medical device is a complex business, with many opportunities to experience pain. And one of those moments that keeps cropping up is Design…

4 steps to create a medical device

Having watched other videos in this series, you’ll appreciate that developing a medical device is a complex business, with many opportunities to experience pain. We’re…

How to make sure your project doesn’t fail

You’ll probably remember our discussion about 5 key things that successful device development projects take care of, to minimise the risk of failure and the…

Failure is expensive, very expensive!

Failure is expensive, very expensive And it gets even more expensive when you’re developing a medical device. Like me, you’d probably like to avoid the…

ISO 13485:2016 – time has run out!

You’ll probably recall me mentioning ISO 13485, and its relevance to ensuring that you don’t fail? If you’ve reached the conclusion that it would be…

Another week, another funding opportunity

Hot on the heels of last week’s article, there’s a further opportunity to get some funding to support your development project. This time, the criteria…

9 changes to FDA goalposts for medical devices

A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a…