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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Operations
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Manufacturing & Distribution
Regulatory
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EU MDR and IVDR
Featured Services
Project Management
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Full Circle Consulting Resources
In this blog, we will explore into the intricacies of the 513(g) process, its significance, and how it aids innovators in achieving regulatory approval for their medical devices.
This blog explores the essence of staff augmentation services, how they work, and the numerous benefits they bring to businesses.
In this blog, we will delve into the key aspects of Annex I of EU MDR and its implications for manufacturers.
In the landscape of global medical device regulation, the European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a significant milestone. Introduced to enhance patient safety and streamline market access for in vitro diagnostic (IVD) devices, the EU IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) and brings with it a host of changes that impact manufacturers, notified bodies, and other stakeholders in the healthcare industry.
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