Since the start of the COVID-19 pandemic, the FDA has had to adjust its approach to in-person inspec...
The medical device industry is already feeling the effects of the Artificial Intelligence (AI) revol...
When contracting with external experts, you may be uncertain about whether to select a consulting fi...
When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultant...
Creating an effective quality system (QS) requires a significant investment of time and resources. T...
Medical device labeling changes are made for a wide array of reasons. When a manufacturer makes chan...
In 2020, the most common reason for FDA's 483 observation letters was "procedures for corrective and...
The key to a successful quality audit is selecting a highly qualified auditor. Since the quality of ...
For FDA (U.S. Food and Drug Administration)-regulated industries, organizations, and projects, the i...
Developing an effective regulatory strategy is more than following the step-by-step requirements out...