Global Leader Archives - EMMA International

EMMA International Consulting Group Celebrates 10 Years of Providing Quality, Regulatory and Compliance Services

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.

EMMA International Consulting Group, Inc. and Thema Announce Strategic Partnership

EMMA International has entered into a strategic partnership with Thema, an Italian based strategic-regulatory consulting company. The goal of this strategic partnership is to expand geographical offerings to companies operating in the life sciences regulated space.

What to Do When Regulations Do Not Work (for You)

Some of the most challenging situations I have had to confront during my career have involved achieving compliance with regulations.

Pattern Recognition as a Quality Superpower

There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”

EU MDR SSCP’s: The Importance of Readability

Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.