Do you have a low to moderate risk medical device that does not have a substantially equivalent predicate device? Are you trying to figure out how to navigate the regulatory pathway for marketing your device? Prior to 1997, with the...
Thomas comes to EMMA International after having served in leadership roles within Boston Scientific, Covidien, Haemonetics and Fresenius Medical Care. Farmington Hills, MI, September 18, 2019 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting, welcomes...
ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name suggests, addresses good clinical practices for all pre- and post-market clinical investigations that determine the safety and performance of medical devices. The final...
Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and Radiological Health (CDRH) is constantly striving towards. Among several other programs introduced or changed over the past couple years, the National Evaluation System for...
Dr. Kuehn Brings Over 20 Years of FDA Regulatory Affairs Experience to the Company’s Regulatory Affairs Team Farmington Hills, MI, August 21, 2019 –E.M.M.A. International Consulting Group, Inc. (EMMA International) a global leader in quality, regulatory, and compliance services for the...
The conference and the course will focus on how FDA is adapting to the digital medical devices era and what companies should know about. Farmington Hills, MI, May 15, 2019 –E.M.M.A. International Consulting Group, Inc. (EMMA International) a global leader in...
This will be the first ever Medical Device Summit held in Michigan Farmington Hills, MI, May 13, 2019 –E.M.M.A. International Consulting Group, Inc. (EMMA International) a global leader in compliance consulting and enterprise quality management software solutions will participate on MichBio’s...
The purpose of this webinar is to discuss the FDA’s voluntary medical device manufacturing and product quality pilot program, CMMI Institute’s role in it and how manufacturers will benefit from this program. Find this webinar and more like it on our...
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...