Since its inception, EMMA International has been dedicated to providing consulting services to help ensure clients’ products advance seamlessly from concept to approval. Throughout this time, the company has continued to grow and expand, solidifying its position as a leader in the field. This growth and success are evident in EMMA International’s multiple recognitions on the Inc 5000 list, which highlights the fastest-growing private companies in the United States. The company’s unwavering commitment to delivering exceptional services and its ability to adapt to an ever-changing industry have been key to its continued growth and recognition.
The End of the COVID-19 Public Health Emergency
After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.
EMMA International’s Body of Knowledge (BOK)
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New Imaging Drug for Ovarian Cancer
In November of 2021, the Food and Drug Administration (FDA) approved Cytalux. Cytalux is a new imaging drug intended to assist surgeons with the identification of ovarian cancer lesions1. This new drug was designed to assist in locating additional ovarian cancer tissues that can be…
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 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
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
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
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
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.
Post-Market Reporting in the EU
With the implementation of the new Medical Device Regulation (MDR) 2017/745 in the European Union, a lot has...
Lost in Translation: Regulating Medical Devices Around the World
In the United States, medical devices are regulated by the FDA. In the European Union, medical devices are...