Two Companies, One Owner; US FDA Sends Warning Letters To Same Address For Similar Issues
Executive Summary
Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.
You may also be interested in...
News We're Watching: LDT Survey Finds Concern, Abbott Recall, New Q-Sub Guidance
This week, the US Congress advanced legislation that would support better cardiac emergency preparedness in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.
As A Young Woman Marissa Fayer ‘Fell’ Into Medtech. Now, As An Industry Leader, She’s Focused On Leveling The Field
Marissa Fayer is dedicated to advancing women’s health. The founder and CEO of HERhealthEQ, a global nonprofit focused on women’s health equity in emerging and developing countries, Fayer is also the CEO of DeepLook Medical. As part of our focus on women’s health in honor of Women’s History Month, Fayer spoke to Medtech Insight about the importance of having more women in all sectors of medtech, both for the benefit of industry as well as women patients.
Day 2: IMDRF Guidance Documents In The Works
Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.