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Does your medical device Risk Management process include Usability / Human Factors Engineering (HFE)? For many devices, the manufacturer must have a process to evaluate the Usability of a medical device as it relates to safety.  This can be accomplished by adding processes to, or integration...

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 to EMMA International’s corporate headquarters...

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 Union, there are even more...