Manufacturing and DISTRIBUTION 

Consulting

Good Manufacturing Practices (GMP) change frequently. Partnering with a global compliance expert will ensure your manufacturing processes stay in compliance with Current Good Manufacturing Practices (cGMP).

EMMA International helps your organization implement and maintain the appropriate processes to support cGMP compliance for the highest level of product quality, safety, and strength. Backed by decades of cGMP experience, EMMA International has the experts on hand to not only manage your compliance project, but also facilitate manufacturing runs and remediate existing operations.

Contact us to find out how we can help your compliance needs.

Our Medical Device CMO

EMMA International proudly partners with New Concept Technology (NCT), a single-source supplier that offers expert design, engineering, process development, fabrication, and manufacturing services. NCT’s facility has a state-of-the-art class 100K clean room that is ISO 1464-1 Class 8 Certified. NCT is considered an expert in medical assembly. They also specialize in medical cable over-molding and medical process automation.

Ready to discuss your next project? Get in touch.

Ready to learn more about working with us?

Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.
Benefits of a QMS

Benefits of a QMS

Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a system that documents procedures, processes, and responsibilities to achieve quality objectives and policies1. Quality management systems can be utilized in many industries especially the pharmaceutical and medical device industries, to provide structure for all processes at a facility.

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