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.

Software as a Medical Device

Software as a Medical Device

Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is....
Decorative Contact Lenses

Decorative Contact Lenses

Decorative contact lenses are a known medical device and are treated with the same standards as corrective contact lenses. Decorative lenses are also known as
Water for Pharmaceutical Use

Water for Pharmaceutical Use

When determining which type of water system is needed for pharmaceutical manufacturing it is important to keep in mind how the water will be applied to the product.
Investigational Device Exemption

Investigational Device Exemption

An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data....
Concepts of Modern Quality systems

Concepts of Modern Quality systems

A quality system's main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve...
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, 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.
Diabetes and Women’s Health

Diabetes and Women’s Health

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.
Innovations in Gendered Heart Disease Research

Innovations in Gendered Heart Disease Research

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.

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