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Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are ...
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene ...
Are you looking to expand your consumer base and grow your business? International marketing is beneficial by ...
Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, ...
An institutional review board, or IRB, is a group of experts who are appointed to monitor and review biomedical ...
Augmented and virtual reality first saw its boom in the consumer sector but has recently piqued the interest of ...
Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified ...
The FDA released two final rules surrounding the classification, and the requirement to submit a pre-market ...
Farmington Hills, MI, January 16, 2020 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a ...
Recently, 3D printing technology has seen a boom in popularity among many different industries, including medical ...
Certification is a formal recognition of the contributions of women in FDA compliance consulting at EMMA ...
The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to ...
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