FDA Labeling Requirements for Point of Care vs. Home Use Devices
A critical decision in designing and developing a medical device is whether it will be used by trained professionals or the general population. This decision will…
The Future Regulation of Laboratory-Developed Tests (LDTs)
This post is part of a two-part series. You can read Part 2 here. Per the FDA commissioner, Dr. Robert M. Califf, and data from the…
Shining A Light on MDR Notified Body Standard Fees
The EU Medical Device Regulations (MDR) has been a looming, dark cloud of change for Medical Device Manufacturers. Whether the discussion is focused on the new…
Internal Audits & Annual Physicals: Is Ignorance Really Bliss?
What Do Your Annual Internal Audit and Annual Physical Have in Common? They both roll around once a year, and both are typically dreaded. Your annual…
How to Simplify Medical Device Reporting Set-Up
What is a Medical Device Report? Medical Device Reports (MDRs) are publicly accessible documents resulting from an event that manufacturers or importers become aware of and…
UKCA Mark Delay – How to Capitalize on the Extension
On October 21, 2022, the Medicines & Healthcare Products Regulatory Agency (MHRA) announced that they are adding a twelve-month extension to the current standstill period on…