This issue explores the sweeping changes caused by the new EU Medical Device regulations (MDR), the global in vitro diagnostics (IVD) market, Industry 4.0 and the Internet of Things.
Related Posts
- 49By Robert Zott, Director of Advisory Services Development Originally published March 27, 2018 It’s easy to read Europe’s Clinical Evaluation Guidance Document MEDDEV 2.7/1 Revision 4 (referred to as “Rev. 4”) and come away with the impression that clinical data—whether in the form of investigations carried out by the manufacturer of a medical device or…
- 45Watch this informative video of a recent panel discussion hosted by Kevin Bouley, CEO, Nerac and David Souder, Interim Dean, UCONN School of Business with Panelists Ripi Singh, Chief of Innovation, Inspiring Next, Mike Accorsi, Senior Associate Dean – UCONN School of Engineering, Jill Mayer, New Haven Manufacturer’s Association, Sudhi Bangalore, VP of Industry 4.0,…
- 44By Donna Mitchell-Magaldi, Nerac Analyst, The global medical device market was valued at $350 billion dollars in 2012 (Mddonline.com, 2012). The US market was valued at $127 Billion dollars in 2013 making it the largest medical device market in the world (Prweb.com, 2013). However, millions of dollars are lost every year due to regulatory noncompliance issues…