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.

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Full Circle Consulting

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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 NIOSH with Medical Devices

The Role of NIOSH with Medical Devices

The National Institute of Occupational Safety and Health (NIOSH) was established in Section 22 of the Occupational Safety and Health Act of 1970. NIOSH began operations in 1971, a year in which the first toxic substances list was published. Since their initiation, NIOSH has grown to not only be a governance body but also a research institute. They are usually at the forefront with other federal departments when human safety is a main risk. Some examples of past human safety risks are the 2001 anthrax attacks, the 2009 H1N1 influenza pandemic, and most recently the Sars-Cov-2 pandemic.
Label Claims for Dietary Supplements

Label Claims for Dietary Supplements

The Food and Drug Administration (FDA) regulates a variety of product categories from infant and toddler foods to snacks to vegetables and meats. One category that falls within the food regulations umbrella is dietary supplements. Dietary supplements are defined to have an intention to add or supplement the diet and are different from conventional foods. Common supplements are vitamins, minerals, botanicals/herbs, botanical compounds, amino acids, and live microbials.
What ISO Certification Means for Your Business

What ISO Certification Means for Your Business

The wonderful thing about Quality is that it is industry agnostic. While certain industries, such as medical device and automotive, do have “special” requirements, the foundation of a Quality Management System is the same industry to industry. Obtaining ISO certification can be more than just a badge of honor for your organization, more and more customers and regulatory bodies are requiring ISO certification, which is why it’s more critical now than ever to consider it for your business.
Staff Augmentation- When Outsourcing Makes Sense

Staff Augmentation- When Outsourcing Makes Sense

Projects and staffing needs can change quickly. The market for high quality talent has never been more competitive. Staff augmentation is an easy and resourceful way to maintain your timelines and stay on budget. By relying on staff augmentation, you can easily outsource workers for staffing needs, timeline, outcomes, and objectives. Staff augmentation easily lets you scale up or down depending on your needs, eliminating the HR struggles of lay-offs, terminations, legal hassles, and documentation of full-time employment.

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