Preparing for the EU Medical Device Regulation
Despite a delay to the EU MDR, there are many changes for medical device manufacturers to put in motion now. Can freelance scientists help?
3D Printing of PPE and Other Medical Devices
Consider the trade-offs of using 3D printing to address current supply demands of personal protective equipment.
Proposal to Postpone EU Medical Device Regulation Underway
A delay of one year could allow authorities and industry to focus instead on urgent responses needed to address the COVID-19 pandemic.
Design Controls, Deconstructed
Here’s what you need to know about design controls and the critical role they play in your regulatory journey.
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third.
