The Failure Mode and Effect Analysis (FMEA) technique is a powerful tool utilized in order to determine all the ...
Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements. ...
Part of the design process is the development of what is known as Design Outputs. According to the FDA “Design ...
The pharmaceutical industry’s response to changes in globalization is unique in that it is governed by ongoing ...
Complying with all regulatory requirements for a regulated product is a massive challenge. Meeting all labeling ...
Heart Disease affects millions of Americans every year, and for that reason, there are many different types of ...
Heart health is an ongoing issue in the United States. While there are many methods to keep a heart healthy, ...
The cornerstone of any regulated industry is a quality management system (QMS). While creating procedures and ...
The FDA has numerous methods of enforcing its regulations, known as enforcement actions. There are 4 total main ...
A remote audit is a way of conducting an audit without being physically present. The overall goal is to evaluate ...
CBD oil is now a part of many consumers' lives, through lifestyle products, food supplements, and even cosmetics. ...
One of the main strategies to eliminate cervical cancer is the consistent screening of people with cervixes. ...