Author: Kira Jabri

Please register for What You Need To Know About The New European Union Medical Device Regulation on Apr 26, 2018 2:00 PM EDT at: https://attendee.gotowebinar.com/register/4765851132747614723 E.M.M.A. International Consulting Group, Inc. is hosting a webinar covering the new EU MDR. Jan Flegeau, Director of Regulatory Affairs, and Dr. Carmine Jabri, CEO, will...

Posted By: Stephanie Bouzounis, Senior Communications Specialist Technology and health care have converged in the 21st century under the umbrella of what is known as digital health. What is digital health? The 21st century has seen the convergence of science and technology. This has resulted in the development...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The deadline for the ISO 13485:2016 transition is fast approaching. In less than a year from now, changes will have to be made in order for companies to keep their certifications. Background The International Organization for Standardization (ISO) is a non-governmental entity...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The European Union (EU) published a new Medical Device Regulation in May 2017, giving manufacturers three years before full implementation in 2020. There are several changes in this new regulation. In a whitepaper by BSI titled, “Planning for implementation of the...

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 at a pharmacy such as...