CDRH New Year’s resolutions

The FDA has shared its New Year’s resolutions, including the guidance documents the Center for Devices and Radiological Health intends to publish in 2016. In…

Top 5 posts of 2015

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…

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…