Redefining distributors in a new light by Deepa Rajagopalan, 2 April 2019 The EU Commission’s new Medical Device Regulation (MDR) significantly changes the importance of economic...
5 Steps to an MDR Audit by Jasminka Roth, 26 March 2019 As you read this, Notified Bodies (NB) are scheduling their first MDR audits—so we’ve...
Yannik Messerli on the art of data by Henrietta Shirley, 19 March 2019 Henrietta Shirley talks to data strategist and infographic designer Yannik Messerli about mastering his...
Create a great Quality Management System by Deepa Rajagopalan, 12 March 2019 Quality is not subjective but defined by that which brings it into being. Classically...
Tracking the UDI System by Deepa Rajagopalan, 5 March 2019 The Unique Device Identification (UDI) system defines the provenance of a medical device and...
Process mapping the route to compliance by Denis Vörös, 26 February 2019 The medical device industry is built on defined processes. These make sure that tasks...
Harnessing the power of market transparency by Jasminka Roth, 19 February 2019 New regulations and initiatives are being built in Europe to create a more transparent...
Begin your data collection for the Eudamed today by Deepa Rajagopalan, 12 February 2019 The European Databank on Medical Devices (Eudamed) will go live from the 25 March...
Secure your business in Europe through MDR compliance by Deepa Rajagopalan, 5 February 2019 The clock is ticking, and time is running out to prepare your organisations’ Medical...
Improving for today and the future by Denis Vörös, 29 January 2019 As we create, we hone our skills. During this process we begin to identify...