As new technologies continuously push the limits of medical devices and drugs, regulations and governing...
Blog
Smartphone-Enabled COVID-19 Test
Becton, Dickinson, and Company, or BD, announced on August 27, that the US Food and Drug Administration (FDA)...
Fiscal Year 2022 Premarket Application User Fees
This past Monday, the FDA announced fiscal year (FY) 2022 medical device user fees. This upcoming fiscal year...
FDA Approves Comirnaty
The day has come where the U.S. Food and Drug Administration finally approves the first COVID-19 vaccination for...
X-Ray Diffraction, a Useful Characterization Technique
X-ray diffraction (XRD) is a non-destructive laboratory technique that assesses the lattice spacing of crystalline...
Pharmaceutical Temperature Mapping
Temperature mapping has become increasingly integrated into regular operations for those who produce or handle...
A QMS Should be Unique, not Universal
Implementing a Quality Management System (QMS) affects every aspect of an organization, including meeting quality...
The Importance of Women in MedTech
Since at least the early 1800s, women have played an integral part in advancing the MedTech industry along. Many...
Designing a Joint Replacement
As technology and science in medicine continue to progress, joint replacements continue to prove a challenge...
World Hepatitis Day 2021
Today, July 28, is observed as World Hepatitis Day. July 28 is the birthday of Dr. Baruch Blumberg (1925-2011)....
The Importance of Supplier Quality for MedTech
It is common knowledge that supplier quality is a critical piece of any MedTech QMS. No matter which regulatory...
The SWIXIT Dilemma for Medtech- Part II
The new EU Medical Device Regulation is set to enter into force on May 26, 2021, which is less than a month away now....
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