A new report from consulting firm Maetrics points to difficult times ahead for regulatory departments in UK healthcare companies. The report, entitled Healthcare and Life Science Regulatory Compliance Report, details results of interviews with officers from 55 UK-based entities, over half of which are medical device firms.
The findings are perhaps unsurprising, given that the respondents are all senior Quality/Regulatory folk. While we’d expect the perpetually toughening regulatory landscape to present challenges to these departments, what we might not have expected to see was that the number one concern for device companies is the unannounced Notified Body inspection.
Read more in our weekly editorial, View from the Med, here.