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.

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, ...
EU MDR: Importers

EU MDR: Importers

The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device ...
The FDA, CBD, and OTC Drugs

The FDA, CBD, and OTC Drugs

‌  When making a new product, whether that product is a drug, a medical device, or a combination product, ...

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