Ensuring Product Clearance & Approval while Remaining Compliant through 510(K) Submissions & UDI Requirements, as well as Addressing International Evolving Regulatory Frameworks, with a Focus on the EU MDR
ABOUT THE CONFERENCE
As device manufacturers continue to bring new and innovative medical technologies to the market, ever increasing requirements from the FDA have resulted in more scrutiny into approval processes and ongoing compliance of products on the market. With budgets throughout the industry already stretched, understanding how to secure regulatory clearance for new medical technologies is critical and challenges reside in increasing amounts of clinical data as well as longer times to market. Furthermore, this conference will address compliance with UDI standards that are continually challenging regulatory affairs teams due to the complexity of the strategy set-up. Changes to regulatory processes will also be discussed at length, with considerable attention focused on new 510(k) regulations, which is still the most popular and commonly utilized approval pathway for the industry.
Although the EU Medical Device Regulations will be explored in great depth in the 2016 conference program, further timely topics will be addressed to ensure a holistic approach to international regulatory affairs challenges and changes. Specific time and focus will be given to the critical update of ISO 13485 and strategies to remain compliance during the transition. Presentations will also highlight products with enhanced technologies such as wireless and mobile monitoring capabilities, where understanding the regulatory clearance pathway is increasingly challenging. With so many regulatory changes to interpret and implement, manufacturers are looking for expert insights, which will be delivered by multiple presenters such as notified bodies, health authorities and distinguished industry executives. To ensure delegates benefit from the most acute learning experience, the program will offer two tracks focusing on approval operations and compliance strategies, allowing for each participant to tailor the learning experience to their specific needs.
This conference has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Eric Jahnke | Marketing Manager | Q1 Productions
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