In 1983, the FDA implemented a lifetime ban on blood donations from people deemed to be “high risk” for potential HIV infection; this included men who have sex with men (MSM). At the time, HIV transmission and infection were not well understood and the tools available to detect the virus were rudimentary.
We can now peer into our genome and microbiome to assess our individual risk of disease, but soon dynamic data will enhance our ability to choose the most effective medical care. Health related apps, trackers and software create robust data sets with the capacity to move personalized medicine into new territory. The real-time communication
Spring conference season is upon us and E.M.M.A. International has just finished an exciting month of conferences with some incredible organizations we work closely with. If you are not familiar with the Medical Device Manufacturers
E.M.M.A. International Consulting Group, Inc., is proud to be a Silver Sponsor of The Manufacturer's Association of Central Pennsylvania’s 2017 Annual Event. This year we will be offering one (1) complimentary ticket to the Annual
Spring is off to a great start for E.M.M.A. International! We are beginning this spring season by offering a new, unique service to those looking to find direction for their quality and regulatory needs. If you’re not sure where you stand with a project, your innovative idea, or whether you should seek ISO certification, for example, but don’t want to dive right into a costly venture right o
MDSAP-What Manufacturers Need to Know In 2014, the International Medical Device Regulators Forum (IMDRF) launched the Medical Device Single Audit Program (MDSAP) pilot. As of 2017, the MDSAP is in full force and fully operational. This poses the...
This is the time of year when many of us tend to retake stock of our homes and lives – we clear the cobwebs, file our taxes, plan our vacations, and generally organize ourselves. So, too, should we reevaluate and organize
E.M.M.A. International was incredibly pleased to have hosted dozens of regional business leaders and innovators at our headquarters in Farmington Hills this month. Our ‘Meet & Mingle’ events are a great way to stay connected with colleagues and
A recall can make all consumers especially nervous, but for a company issuing such an action, this can be evermore daunting, though it doesn’t need to be. A recall is essentially a removal
President Donald Trump, in his first few weeks in office, has been forging ahead with executive orders, making good on promises made while campaigning. He has signed one such executive order (EO), “Reducing Regulation and Controlling Regulatory Costs”(1), which intends to