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…

FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories. Often, manufacturers…

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…

Two little words… many interpretations

Risk Management… … Two words that can elicit impassioned debate and sharp disagreement within an organisation, even with ISO 14971 in place to help! We’ve…

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…