Join this webinar to gain practical insights and to participate in an extended Q&A session from featured speakers with expertise from multiple MDR geographies.
TORONTO (PRWEB)
March 03, 2022
With the European Union (EU) Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the MDR and introducing new products. Although Medical Device Coordination Group (MDCG) full guidance is forthcoming, there remain significant gaps in guidance and interpretation of requirements and varying interpretations of expectations. In addition, with the limited number of Notified Bodies designated under MDR, there is substantial pressure to ensure MDR applications are submitted as soon as possible to avoid the “cliff edge” of May 2024.
The clinical and regulatory challenges are broad and include: strategies for PMCF and implementation of those activities, making new clinical investigation submissions and presentation of clinical data within the MDCG and Medical Devices Documents (MEDDEV) framework, to name a few.
Join this webinar to gain practical insights and to participate in an extended Q&A session from featured speakers with expertise from multiple MDR geographies.
Join experts from NAMSA, Adrian Keene, Senior Director, Global Biological Safety and Validation and EMEA Consulting Services; Jane Arnold-Round, Principal Regulatory Scientist; and Sara Finocchietti, Senior Clinical Study Manager, for the live webinar on Thursday, March 24, 2022, at 9am EDT (1pm GMT/UK).
For more information, or to register for this event, visit Clinical Challenges under the EU MDR.
ABOUT NAMSA
Helping MedTech Sponsors improve healthcare since 1967, NAMSA is the world’s only 100% medical device-focused, full continuum Contract Research Organization (CRO). Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services; NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Web: namsa.com.
Contact:
Leah Davidson
Tel: +1 (612) 615-6985
Email: ldavidson@namsa.com
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