Are you developing a medical device? And are you certain about that? It might sound like a crazy question. If ...
Are you developing a medical device? And are you certain about that? It might sound like a crazy question. If ...
One of the main challenges of implementing a Quality Management System (QMS) is ensuring it is actually used f...
It's been a while since I've blogged so I thought it would be good to get 'back in the saddle' by getting back...
It’s a cliche that good collaboration and teamwork maximises productivity. But in the high tech product develo...
Developing medical devices can be a process fraught with challenges. As a startup or established business abou...
4 steps to getting ISO9001 ready Achieving ISO9001 compliance can appear daunting, but while it requires a sig...
A closer look at Document Control for ISO9001 What is document control? Properly documented information is at ...
One of the areas included in the Final Draft of the ISO 9001 revision (ISO/FDIS 9001:2015) is 7.1.6 Organizati...
For the past several months we've published a series of blog posts on the application of Risk-based Thinking f...
