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

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Full Circle Consulting Resources

The eSTAR 510k

The eSTAR 510k

The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) document that seeks to make 510(k) and De Novo submissions quicker and easier due to its automation from its form construction and autofill capability
Medical Device Reporting

Medical Device Reporting

Medical device reporting (MDR) is one of the post market surveillance tools used by the FDA to monitor medical devices’ performance post release (21 CFR part 803)
Artificial Intelligence and Machine Learning in Drug Development

Artificial Intelligence and Machine Learning in Drug Development

With the growth of computational capabilities, artificial intelligence (AI) and machine learning (ML) have become a beacon of interest from both the product development side and the regulatory side. Implementation of AI and ML methodologies into the day-to-day life of our society is a real and ever-growing adaptive process. The FDA has just released a document that facilitates discussion and brings about important ideas for its place in society and how it will be regulated [1]. In 2021, over one hundred submissions to the FDA included some usage of AI/ML [2].
The History of The Food and Drug Administration (FDA)

The History of The Food and Drug Administration (FDA)

In 1906 the Pure Food and Drug Act (Dr. Wiley’s Law) was passed by the Congress and signed by President Theodore Roosevelt, bringing the governing body of the Food and Drug Administration (FDA) into existence. The first commissioner of the FDA was Dr. Harvey Washington Wiley, who previously was the chief chemist of the USDA Bureau of Chemistry [1]. Previously to the FDA, the Bureau of Chemistry regulated food safety. The implementation of the FDA was the first comprehensive consumer protection agency in the federal government [1]. The first glimpse into what would eventually become the FDA, was the U.S Pharmacopeia which was started back in 1820 and sought to standardize drugs [2].

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