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.

Annual Drug Product Reviews

Annual Drug Product Reviews

If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs ...
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the ...
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration ...
Benefits of a QMS

Benefits of a QMS

Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a ...
What is a Fishbone Diagram?

What is a Fishbone Diagram?

A Fishbone diagram is a risk management tool used to visualize cause and effect to analyze the root cause of a ...
When To Write A CAPA

When To Write A CAPA

A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue ...
Decorative Contact Lenses

Decorative Contact Lenses

Decorative contact lenses are a known medical device and are treated with the same standards as corrective contact ...

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