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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as an online workshop. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
The EU MDR significantly changes the regulatory framework for placing any new medical device on the market, but it does not provide any specific instruction for applying the new requirements to legacy devices with valid certifications under the MDD.
Legacy devices cannot be “grandfathered” into compliance and the implications are significant, from updating technical documentation to changing product labels and demonstrating robust clinical evidence. Manufacturers must ensure their transition plan meets these new requirements in order to continue marketing their devices on the EU market.
Join RAPS for a two-day workshop to ensure your transition plan includes the key requirements for device compliance on the EU Market.
This workshop is aimed at the mid-level regulatory affairs professional who is responsible for applying the EU MDR requirements to his/her organization’s products. Knowledge of the MDD is not required but does help provide a better understanding of the impact of the changes on legacy products and will enable attendees to leave the workshop with a clearer path for creating the transition plan.
RAC Credits: 12 (Upon attending and completing the program)
Program Schedule
Topics will include (but are not limited to):
Wednesday, 23 September (9:00am–5:00pm)
Thursday, 24 September (9:00am-5:00pm)
In group activities, attendees will work on:
NOTE: The agenda may vary based on changing requirements. This workshop will be recorded.
Faculty
Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Services, where she works with medical device, dental and IVD companies to implement ISO 13485 and FDA QS Regulation compliant quality management systems; incorporate processes to comply with FDA, EU and other international regulatory requirements related to quality systems, risk management; and regulatory compliance related to labelling and Unique Device Identification (UDI) requirements. She is a member of AAMI Sterilization Standards, ISO/TC 198 and ISO/TC 210 work groups. She is a member of ASQ, and as a member of Regulatory Affairs Professionals Society (RAPS), serves as the chairperson for the Twin Cities Chapter, is a member of the RAPS European Committee (REC), and a leader of the UK Local Networking Group.
Mindy has broad and multi-faceted experience in medical device international regulatory affairs and quality management, having worked for a start-up, large global company and two notified bodies, before joining Qserve, a medical device consulting company. Mindy’s enthusiasm for regulatory compliance, communication skills and leadership skills make her an effective project manager and engaging trainer. Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and regulatory and business executive has led to a practical approach in developing and implementing regulatory strategies and quality procedures; auditing; and writing and reviewing clinical evaluation reports, technical documentation, and clinical investigation protocols and applications.
Pricing
Before 23 August:
Member – $800
Nonmember – $900
24 August – 21 September 2020
Member – $900
Nonmember – $1,000
Cancellation or Substitutions
RAPS reserves the right to cancel this program at its sole discretion.
All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.
Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.
Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.
Questions
Call RAPS Solutions Center at +1 301.770.2920, Ext 200
Program Contact
Stephany Evans
sevans@raps.org
+1 301 770 2920 Ext 229