Need to create or update your Medical Device Clinical Evaluation Reports? Published in June 2016 by the European Commission, MEDDEV 2.7/1 ‘Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, the new guidance document is much more explicit on how to undertake a robust and systematic clinical evaluation, and how […]
We are thrilled to announce several promotions within Real Regulatory. Dorothée Fouchier has been promoted to Managing Consultant of our Dublin office. Dorothée joined the company in 2006 and during her time with us she has managed Real Regulatory’s in-company and consulting services to provide clients with the strategic advice and guidance they need for […]
Ireland
Unit 9A
Plato Business Park
Damastown
Dublin 15
D15 PA4C
United Kingdom
E-Space North
181 Wisbech Road
Littleport
Ely
Cambridgeshire
CB6 1RA
U MDR-2020 Deadline
The 2020 deadline for compliance with EU Medical Device Regulation (MDR) is fast approaching for medical device companies who want to remain in one of the world’s largest markets. A recent survey (June 2018) by KPMG/RAPS “The Race to EU MDR Compliance” of 200 regulatory and quality professionals at medical device companies around the world. reported the following:
• 78 % of medical device companies do not have a sufficient understanding of EU MDR.
• 58% of respondents have no strategy in place to remediate gaps in their clinical data or processes for collecting data.
• 45% of North American and 29% of European respondents were “not very confident” of being able to meet the regulatory deadline.
The survey results show that compliance with EU MDR is a major challenge for medical device companies. RRL can ensure your company is 2020 ready by guiding you through the requirements of the EU MDR and helping you develop a comprehensive EU MDR implementation plan. Contact RRL at bit.ly/2zXp9Vb and get 2020 ready now.
U MDR-2020 Deadline
The 2020 deadline for compliance with EU Medical Device Regulation (MDR) is fast approaching for medical device companies who want to remain in one of the world’s largest markets. A recent survey (June 2018) by KPMG/RAPS “The Race to EU MDR Compliance” of 200 regulatory and quality professionals at medical device companies around the world. reported the following:
• 78 % of medical device companies do not have a sufficient understanding of EU MDR.
• 58% of respondents have no strategy in place to remediate gaps in their clinical data or processes for collecting data.
• 45% of North American and 29% of European respondents were “not very confident” of being able to meet the regulatory deadline.
The survey results show that compliance with EU MDR is a major challenge for medical device companies. RRL can ensure your company is 2020 ready by guiding you through the requirements of the EU MDR and helping you develop a comprehensive EU MDR implementation plan. Contact RRL at bit.ly/2zXp9Vb and get 2020 ready now.
All set up for the next 2 days at ICDRA @ Clayton Hotel Burlington. Pop in and say hello!
