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…

Is herding cats easier than Design Controls?

With increasing pressures on healthcare businesses to get to market quicker and pressure to lower development costs, managing your design controls activities effectively has never…

Zen and the Art of Design Controls

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…