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.
COVID-19
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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EU MDR Delays
It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.
EU MDR Common Specifications Are Not Common
A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).
COVID-19 Fraudulent Products
It has been a wild past two years trying to figure out what products can mitigate, treat, diagnose or even cure...
FDA One Step Closer to Approving EUA for COVID Vaccine for Children Ages 5 – 11
So many parents, who have been on a continuum of anxiousness since the beginning of the pandemic, were finally...
What to Look for in an Authorized Representative
As communication and travel have become easier, companies that were once destined to serve only a small area...
A Safe Halloween During Covid-19
The pandemic has changed quite a bit about our way of life. Despite how much has changed, kids will always be...
Preparing for the End of Your EUA
An EUA (Emergency Use Authorization) was, until recently, rarely given. With the start of the COVID-19...
Rise of Infections at Healthcare Facilities
Health officials have noted that rates of infection have decreased at healthcare facilities before the...
Eli Lilly’s COVID-19 Drug Combination
At the beginning of the pandemic in 2020, Eli Lilly, a pharmaceutical company, joined forces with Junish...
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