It’s All About The User
August 13 2019
However great your device design and technology may be, it still needs to work for the users, answer their needs, accommodate their constraints and expectations…
Archive
Getting Your Design Right
August 6 2019
Coming up with a design for your medical device that can be manufactured, assembled at a low cost, whilst ensuring it does what users need…
A route to Regulatory Compliance: Part 2 – Quality Management
July 30 2019
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…
A Route to Regulatory Compliance: Part 1: Design Controls
July 23 2019
Developing a medical device is a complex business, and compliance with regulations and quality requirements is a key component of success. How would it…
4 W’s of Design Review
July 16 2019
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
July 9 2019
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 navigate complexities of medical device development
July 2 2019
It’s a complex business, developing an idea into a medical device. And it’s complicated by the myriad of important things you need to address, to…
How to make sure your project doesn’t fail
June 25 2019
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!
June 18 2019
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!
May 8 2019
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…