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

Record Control for a Regulated World

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

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.
Key Performance Indicators Unlock Potential

Key Performance Indicators Unlock Potential

There are right and wrong approaches for using measures to achieve performance improvement. Knowing the difference requires some book-learning, but mostly the wisdom of broad and deep experience.
The Digitalization of Quality Management Systems

The Digitalization of Quality Management Systems

One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.

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