Absent MRA, immanent MDR: Actions for Swiss medtech by Jasminka Roth and Deepa Rajagopalan, 17 January 2020 The situation around the bilateral agreements and the MRA (Mutual Recognition Agreement) between the...
Bridging the gap in MDR implementation by Henrietta Shirley, 23 October 2019 Quality Implementation Manager Deepa Rajagopalan talks to Henrietta Shirley about MDR implementation and bridging...
Regulatory strategies for the MDR by Jasminka Roth and Henrietta Shirley, 15 October 2019 Following the intensive workshop (Tactical Session) we recently presented in Schaffhausen—and reported in the...
Accessing funding and reimbursement in medtech by Jasminka Roth, 8 October 2019 Funding and reimbursement systems pay for medical devices. However, accessing these systems effectively and...
Evaluating your clinical data under the MDR by Jasminka Roth, 1 October 2019 The MDR has left many manufacturers wondering whether they have enough clinical data to...
MDR & IVDR Tactical Session: working with a Notified Body by Jasminka Roth, 24 September 2019 For many medtech companies, particularly SMEs, finding and working with a Notified Body can...
How does regulation affect innovation? by Deepa Rajagopalan, 10 September 2019 The human mind is curious. It is our inquisitiveness that has led to some...
Key research for medical device manufactures by Jasminka Roth, 13 August 2019 How does regulation affect innovation? We are built to explore, to travel, to move...
The MedTech Diary: regulation and innovation by Henrietta Shirley, 23 July 2019 We’ve collected the best dates in medtech coming up over the next few months...
The Basic UDI and its role by Deepa Rajagopalan, 16 July 2019 The Official Journal of the European Union (OJEU) has announced four UDI Issuing Entities...
