The medical device industry is already feeling the effects of the Artificial Intelligence (AI) revol...

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...
Quality managers everywhere will attest to the fact that effective document control is critical to t...