by digitalrefresh | Oct 27, 2021 | Blog
So, four years after it entered into force, the Medical Devices Regulation (MDR) is now here. It became applicable on the 26 May 2021. The implementation has been slow, and it has been very frustrating for all those working in the Medical Device Industry, not knowing...
by digitalrefresh | Aug 27, 2021 | Blog
Working within a laboratory in a Clinical Trial environment is a complex role. One small action can have major impacts on the outcome of an experiment. This blog explores some of the most common ways in which errors to GLP guidance occur. 1. Not evaluating the results...
by digitalrefresh | Apr 3, 2021 | Blog
At some point, we’ve probably all seen the spectacular sight of geese flying together in a V. Why do they do this and what can we learn about leadership from it? Each bird flies slightly above the bird in front of them, reducing wind resistance. The geese take turns...
by digitalrefresh | Mar 6, 2021 | Blog
Throughout our projects, we create milestones to help us ensure we are remaining grounded to the project and to allow an update to all involved. The use of milestones is more or less a scheduling strategy. For example, if the project was a wedding, the milestones...
by digitalrefresh | Dec 13, 2020 | Blog
What is a medical device? The FDA defines a medical device as: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the...
