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
A 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device manufacturers to demonstrate that their device is safe and effective for its intended use. The process is required for devices that are not exempt from premarket notification requirements. This article outlines the steps involved in obtaining a 510(k) clearance.
Whether looking to update an existing process or implement something brand new, process design is a critical ...
Since its inception, EMMA International has been dedicated to providing consulting services to help ensure clients' products advance seamlessly from concept to approval. Throughout this time, the company has continued to grow and expand, solidifying its position as a leader in the field. This growth and success are evident in EMMA International's multiple recognitions on the Inc 5000 list, which highlights the fastest-growing private companies in the United States. The company's unwavering commitment to delivering exceptional services and its ability to adapt to an ever-changing industry have been key to its continued growth and recognition.
Accurate and precise measurements are vital in the pharmaceutical, medical device, and other FDA regulated ...
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