As new technologies continuously push the limits of medical devices and drugs, regulations and governing...
Remediation
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...
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...
ISO 13485 & QSR Harmonization
For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...
What is Remediation?
If you are in the medical device industry, chances are you’ve heard of Remediation. But what exactly is it? Is it...
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