Full Circle Consulting

EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.

Full Service

Full Circle Consulting

When

Product Development

Regulatory Submissions

Post Market Compliance

Manufacturing and Distribution

Why

Regulatory Strategy

Quality System Development

Quality System Implementation

EMMA OnDemand

Featured Services

COVID-19

EU MDR and IVDR

MDSAP

Ready to learn more about working with us?

Full Circle Consulting Resources

GDP PRACTICES

GDP PRACTICES

Across all industries, documentation is a key aspect of maintaining good quality and traceability over products. Therefore, having good documentation practices (GDP) is an essential tool and something that requires repetitive training to ensure proficiency. Especially in the life science industries, having good documentation improves overall product quality and allows for clearer traceability and validation within processes. GDP practices can be done using the acronym, ALCOA, which stands for Attributable, Legible, Contemporaneous, Original, and Accurate.
The 510K Process

The 510K Process

A 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device manufacturers to demonstrate that their device is safe and effective for its intended use. The process is required for devices that are not exempt from premarket notification requirements. This article outlines the steps involved in obtaining a 510(k) clearance.
Quality Through Automation

Quality Through Automation

Whether looking to update an existing process or implement something brand new, process design is a critical ...
EMMA International Consulting Group Celebrates 10 Years of Providing Quality, Regulatory and Compliance Services

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.

Pin It on Pinterest