Madison Wheeler, Author at EMMA International

Changes to OTC Sunscreen Labeling

‌ OTC Sunscreen manufacturers can expect to see some major changes coming their way soon, with the announcement...

‌ The FDA has begun tackling AI/ML software as a medical device (SaMD) this year, but there was a noticeable...

‌ Ovarian cancer is one of the most common forms of cancer affecting female-born patients. About 21,000 people...

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services…

Since at least the early 1800s, women have played an integral part in advancing the MedTech industry along. Many...

For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...

While a Quality Management System (QMS) is a necessary and foundational element of any life-science...

Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was...

Happy National Women’s Health Week! In honor of this week bringing light to important women’s health issues, I wanted...

It is common knowledge that supplier quality is a critical piece of any MedTech QMS. No matter which regulatory...

If you have developed a medical device, you know how important the concept of traceability is. Every facet of the...

A critical, yet often overlooked, part of bringing your medical device to market is ensuring it complies with all...