Quality

We design, build and implement Quality Management Systems (QMS) for organizations of all sizes across the Life Sciences industry.

Regulatory

We deliver high quality, cost-effective solutions by accelerating the regulatory approval process for firms in the Life Sciences industry.

Compliance

We provide sustainable solutions for FDA regulations and help organizations in the Life Sciences industry in the US and internationally.

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EMMA International is a leading FDA compliance consulting firm. We provide cost-effective solutions for FDA regulatory affairs, compliance services, regulatory filings and submissions. Our expertise includes medical devices, biotechnology and pharmaceutical services.

We’d love to talk to you about how we can help your business succeed.

News from EMMA INternational

Medical Device Data Systems (MDDS) are hardware or software products that are intended to transfer, store, convert document forms and display medical device data. MDDS on its own does not modify the data or control any functions of the connected......

In my software engineering career, I was lucky enough to work on some amazing frameworks and technologies, but nothing compares to the features and computing power enabled by Artificial Intelligence (AI). It is often utilized in cases of predictions,...

Last week, the FDA published a safety communication on how the accuracy of pulse oximeters can be affected by skin pigmentation. Specifically, there were concerns that darker skin pigmentations can considerably affect the validity of results read fro...

SEAMLESS QUALITY MANAGEMENT

Imagine all the advantages of going paperless. Even more, imagine streamlining your Quality Management System. QualiPro is an Enterprise Quality Management Software (EQMS) provided only by EMMA International. QualiPro is the road to compliance for firms in the Life Sciences industry.

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