‘Crazy Busy’ or Controlled Busy?
Let’s borrow a practice from the medical profession, and Triage our work.
Risk Assessment - What Are We Learning?
The documentaries The Bleeding Edge (2018), and The Implant Files (2019), increased awareness of the impact of insufficient risk assessment.
The Impact of EU Medical Device Regulation Deadlines
In May of 2017 the EU passed its revised Medical Device Regulations (MDR) and InVitro Device Regulations (IVDR).
Medical Device Acronyms - DHF, DMR, DHR
Three of the most connected and confused are DHF, DHR, and DMR. Let’s unpack them together.
