https://youtu.be/nZQkE7wxD2c Compliance with regulations and quality requirements is a key component of success when you’re developing a medical device. If you had a good feel for what you need to take care of for this, what would you do? In this bite-size...
For years there’s been an indistinct, blurry area, surrounding software and apps that are deemed medical devices and so called “wellness” or “lifestyle” applications. Signs of change have emerged over the past few months, in the US at least. And where the US leads,...
We are delighted to have won a tender to supply regulatory guidance, CE marking and support services to companies developing medical technologies, via the Keele University and University Hospitals of North Midlands NHS Trust (UHNM) Business Bridge programme....
Would you like our eternal gratitude… and a small scale model of a speed boat? (yes, really…) Three Circles, the leading medical device development consultancy, have commissioned bespoke research into the industry’s perceptions of best practice, areas of risk, and the...
Spring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September. Children learn and...
During 2015 we dipped our toe in the water, posting thoughts and tips both on our website and LinkedIn Pulse. At the close of the year, the results are in and one thing the top posts have in common is the sharing of difficulties and practical ways to overcome them....
There are days when I think “is it me?” Especially when it comes to appreciating Quality Systems. I confess I do like logic and I even get a buzz when I see a logical progression in project deliverables, moving from A to B to C and so on. It’s wonderful, having links...
After I wrote about the MDA's approach to device development (here's the post), several people emailed me to find out more. Perhaps, like them, you're curious about it? Feed your curiosity by reading this brief summary of the four steps; Define - Develop -...