From paper to eQMS: Part 2 by Denis Vörös, 4 June 2019 A seamless transition to the new regulatory requirements of the EU’s Medical Device Regulations...
Identify your PRRC by Deepa Rajagopalan, 28 May 2019 The EU’s new Medical Device Regulation (MDR 2017/745) identifies the key requirements an organisation...
The MDR with one year to go by Deepa Rajagopalan, 14 May 2019 Next week, it will be exactly 1 year until the EU Commission’s (EC) new...
Taking a closer look at the MDR by Deepa Rajagopalan, 16 April 2019 When the new MDR was first announced in May 2017, we saw it at...
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...
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...
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...
MDSAP replaces CMDAS in Canada by Denis Vörös, 14 January 2019 As announced for the first time by Health Canada in April 2016, the 1...
