Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

DFMEA

DFMEA

The Failure Mode and Effects Analysis (FMEA) tool allows an organization to examine the possible hazards and risks ...
GDP: ALCOA+

GDP: ALCOA+

Good documentation practices are essential to your company’s pharmaceutical quality system and quality risk ...
National Engineers Week

National Engineers Week

It is one of our favorite times of year here at EMMA International, National Engineers Week! National Engineers ...
Tools for Supplier Management

Tools for Supplier Management

Suppliers play a critical role in the production process. Whether they are a CMO who produces the finished product ...
PFEMA

PFEMA

The Failure Mode and Effect Analysis (FMEA) technique is a powerful tool utilized in order to determine all the ...
Intended Use Validation

Intended Use Validation

Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements. ...
Design Outputs

Design Outputs

Part of the design process is the development of what is known as Design Outputs. According to the FDA “Design ...
Regulation and Labeling

Regulation and Labeling

Complying with all regulatory requirements for a regulated product is a massive challenge. Meeting all labeling ...
Love and Heart Disease

Love and Heart Disease

Heart Disease affects millions of Americans every year, and for that reason, there are many different types of ...

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