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…

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…

What difference does a year make?

A little over a year ago, I was fortunate to be involved in the AAMI/FDA summit on healthcare technology in the home setting, in Washington…