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

Equipment Validation

Equipment Validation

Accurate and precise measurements are vital in the pharmaceutical, medical device, and other FDA regulated ...
The environmental monitoring program in sterile drug manufacturing

The environmental monitoring program in sterile drug manufacturing

Many controls are well-designed and put in place to help drive and maintain the quality of the sterile drugs produced by aseptic processing. Perhaps one of the most important controls is the environmental monitoring (EM) program. The main purpose of the program is to document the state of control of the facility and aseptic process; however, it does not determine the quality of the finished drug product.
Supplier Controls

Supplier Controls

How does a medical device manufacturer make sure that they prevent garbage from coming into their factory, and therefore lessen the ways that garbage can go out?  Supplier controls are a set of useful tools to evaluate potential suppliers for product quality, as well as other important capabilities of suppliers.  It’s not just a good idea, it’s the law, according to 21 CFR 820.50.
EU MDR: Extending the Transition Period for Medical Devices

EU MDR: Extending the Transition Period for Medical Devices

The European Commission has implemented a proposal to extend the transitional period to certify medical devices under the Medical Devices Regulation (MDR). The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation

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