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.

How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, ...
Electronic Post Market Safety

Electronic Post Market Safety

The Food and Drug Administration (FDA) recently finalized the guidance for post-market safety reports of biologics ...
Principles of Data Integrity

Principles of Data Integrity

Data integrity is one of the most critical factors in any regulated industry. This is because any data error could ...
Particulates in Final Product

Particulates in Final Product

Visual inspections ensure that visible particulates are not present in products manufactured by an organization. ...

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