February 15, 2024
FDA Proposes New Sterilization Requirements For Medical Devices
The industry is moving away from ethylene oxide (EtO) [...]
Category: Featured
February 8, 2024
GxP Compliance: Guide To Create A Safe, Effective And Usable Plan
In the rapidly evolving landscape of industries such as [...]
February 1, 2024
AI In Medical Devices: How Does The FDA Regulate To Reduce Patient Risk?
AI (artificial intelligence) algorithms are now able to make [...]
January 25, 2024
Why Is Good Engineering Practice [GEP] Important In The Pharmaceutical Industry?
Every industry has some kind of associated risk – some are [...]
January 18, 2024
Validation Essentials For High-Risk Medical Devices & Pharmaceuticals
Validation is a requirement for medical devices and [...]
December 23, 2023
How To Create An Effective Compliance Program
Discussions about New Year’s Resolutions are common, yet it [...]
December 21, 2023
Guidance On Cybersecurity For Medical Devices
I have a niece who is a nurse, a traveling nurse, who floats from [...]
December 7, 2023
MDD Vs. MDR: What’s The Difference?
When MDR was first introduced, it marked a major shift from MDD, [...]
November 23, 2023
Cleaning Validation Process Guidelines: How To Ensure Compliance
Cleaning validation regulations are pivotal in ensuring [...]