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Paper Based QMS vs EQMS When looking at a document management system, companies have two choices; paper based or electronic. In our experience, companies often tell us that, ‘they have been talking about an EQMS’ for a significant amount of time...

E.M.M.A. International Consulting Group, Inc. (EMMA International) a global leader in quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries, is pleased to announce the opening of its newest office location in Grand Rapids, MI. In addition...

Independence Day is a time to celebrate our country with family and friends. July 4th is synonymous with fireworks, swimming and picnics. However, the fun of picnic and barbeque season can also bring on additional opportunities for foodborne bacteria to...

What is FSMA? The FDA Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama in 2011. This enables the Food and Drug Administration (FDA) to provide oversight, ensure compliance with requirements, and respond effectively to problems....

Posted by Stephanie Bouzounis, Senior Communications Specialist   Daily consumers use and consume products that have the potential to harm or enhance their health. Medications, food, and medical devices are all regulated by the Food and Drug Administration (FDA). Cosmetics, like these...

Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical devices – like we mentioned in last week’s blog – fall into one of three classes: Class I, Class II, and Class III. Class I devices are low risk, and include over-the-counter items found...

Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical device manufacturers have much to think about when it comes to registering a product internationally. Different regions and countries have different standards for registration. With the impending divorce of the U.K. from the European...