Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

Design Outputs

Design Outputs

Part of the design process is the development of what is known as Design Outputs. According to the FDA “Design ...
Regulation and Labeling

Regulation and Labeling

Complying with all regulatory requirements for a regulated product is a massive challenge. Meeting all labeling ...
Love and Heart Disease

Love and Heart Disease

Heart Disease affects millions of Americans every year, and for that reason, there are many different types of ...
The Value of Training in QMS

The Value of Training in QMS

The cornerstone of any regulated industry is a quality management system (QMS). While creating procedures and ...
FDA Enforcement Actions

FDA Enforcement Actions

The FDA has numerous methods of enforcing its regulations, known as enforcement actions. There are 4 total main ...
Ending a Recall

Ending a Recall

All things must inevitably come to an end, including a medical device recall. Whether voluntary or FDA mandated, ...

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