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Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.
In honor of this week being National Women’s Health Week, it’s important to not only speak about the illnesses and ...
In honor of this week being National Women’s Health Week, it is important to touch on the topic of infertility. ...
Heart disease is the leading cause of death in the United States equally impacting all. Being Women's Health Week, we want to highlight the impact heart disease has on the livelihood of women and what new developments there are in the life sciences innovation world that would reduce the impact it has on society.
Heart disease is the leading cause of death in the United States equally impacting all. Being Women's Health Week, we want to highlight the impact heart disease has on the livelihood of women and what new developments there are in the life sciences innovation world that would reduce the impact it has on society.
National Packaging Design Day is a special day for professional designers, a day to celebrate the art of packaging ...
In regulated industries, the quality of the product is essential. Incoming inspections help monitor suppliers, ...
The Food and Drug Administration (FDA) recently finalized the guidance for post-market safety reports of biologics ...
The Food and Drug Administration (FDA) recently debuted a new eligible health claim for magnesium. In early ...
Risk Assessments are a powerful tool used to elevate regulatory decisions and product changes. Risk assessments ...
Data integrity is one of the most critical factors in any regulated industry. This is because any data error could ...
Visual inspections ensure that visible particulates are not present in products manufactured by an organization. ...
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