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

EMMA OnDemand

Quality

Quality System Development

Quality System Implementation

Post Market Compliance

ISO Standards Consulting

Operations

Product Development

Manufacturing & Distribution

Regulatory

Regulatory Strategy

Regulatory Submissions

EU MDR and IVDR

Featured Services

Project Management

Staff Augmentation

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Full Circle Consulting Resources

The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.
Managing Risks

Managing Risks

All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis., the same goes with medical devices.
The Significance of Design Controls

The Significance of Design Controls

In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.

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