The COVID-19 pandemic has introduced unprecedented challenges to the medical device and life-sciences industry. From PPE shortages, remote audits, delays in regulatory processes, and much more.
EMMA International has stayed on top of the ever changing quality and regulatory landscape amidst the global public health emergency and has compiled the following resources to keep the life-science industry informated, to ensure life-saving products get to market, and stay on the market.
Since the introduction of the term by Seth Frank back in 2000 , the idea of digital health has revolutionized many of our current healthcare and global health practices. With roughly 6 billion USD in funding in 2017, the development of digital health technologies and the systems in which they run were appearing at an extremely rapid rate [1,2]. Currently, the FDA categorizes digital health into mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine [2,3].
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.
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.