ASQ New England Discussion Group (NEDG)
Presents by request:
VIRTUAL WEBINAR:
EU Medical Device Regulation-
Application Process
June 12, 4:00-6:00 PM ET
Introduction to the EU Medical Device Regulation Application Process
Session Topics:
- Overview of the MDR Application Process and Interaction with the Notified Body
- Structuring and Organizing Technical Documentation
- Understanding Classification Rules
- General Safety and Performance Requirements (GSPR)
- Essential Components of Clinical Evaluation
- Key Elements of Biological Evaluation Reports
- Labeling and Instructions for Use (IFU)
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
Key Learning Objectives:
- Gain a comprehensive understanding of the MDR application process and expectations when engaging with a Notified Body
- Learn best practices for organizing and presenting technical documentation
- Identify critical elements that regulatory reviewers prioritize during the assessment process
- Understand how the EU MDR impacts your Quality Management System (QMS)
SPEAKERS:
|
Sue Finneran, President Regulatory Compliance Experts, Inc.
|
Sue Finneran is the President of Regulatory Compliance Experts, Inc. and has led the organization for the past 10 years.
The company is focused on partnering with small and mid-size medical device companies to develop and execute quality and regulatory strategies to bring innovative products to market.
Ms. Finneran has over twenty- five years of experience in the area of Regulatory Affairs, Clinical Operations, and Quality Systems. She has extensive experience preparing FDA applications, CE marking, and international registrations.
The company also assists clients with implementing Quality Management Systems, conducting internal audits, and many other aspects of QMS management.
Prior to taking on her current role, Ms. Finneran held various positions at the VP/ Director level in the areas of Regulatory Affairs and Clinical studies in the Boston Area.
|
|
Dennis Shay, Health Quality and Regulatory Affairs Director, Best Buy Health
|
With a background in science and engineering and extensive medical device/IVD regulatory experience, Dennis can quickly understand new and complex technologies, develop creative strategies to complex problems, and lead teams to successful product launches.
Dennis has established a successful track record of leading medical device and in-vitro diagnostic companies through difficult Regulatory challenges, with some of his past efforts being obtaining a COVID-19 EUA, writing and submitting a Class III PMA for an FDA up-classification of defibrillation accessories, submission of software-driven, electromechanical Class II infusion pump devices to FDA, converting a portfolio of Class I and IIa EU technical documentation from MDD to MDR compliance, leading efforts to implement a state-of-the-art Regulatory Information management System (RIMS), and converting a contract manufacturer from zero to ISO 13485 in 6 months.
Dennis has a B.S. and Ph.D. in materials science and engineering from Penn State and the RAC-Devices certification (2025).
|
Program Charge:
· Registration Fee $49.00 Note: Registration for this program ends Monday June 9, 2025 at 12:00 PM to enable all attendees to receive their log-on information.
Event Refund Policy:
We unfortunately cannot offer refunds for cancellations made within 1 week of this event. Refunds requested prior to one week will be honored, however, the sign-on fees from Member Planet will be charged. Substitute or replacement people are always permitted. Please contact the program chair listed if a change is to be made to ensure we have the most up-to-date information on the event’s attendee.
Attendance Certificate Credit:
This will be supplied via email after the webinar with attendance confirmed for the event and released slides.
0.5 RU
Registration Information:
go to: https://mp.gg/kqzoankdem
or scan QR Code:
Send your questions to:
Program Chairs,
Sue Finneran, sue.finneran@gmail.com
Dennis Shay, dpshay@gmail.com
Be an Event Influencer – Share Your Expertise or Suggestions:
We invite you to actively shape the content of our upcoming Quality Management System (QMS) sessions. If there are specific QMS topics you would like to see covered in future sessions, we encourage you to share your suggestions with us.
Additionally, if you are interested in presenting a topic as part of our multipart program series, we would be pleased to hear from you. Under the ASQ umbrella, our mission is to meet the educational needs of our attendees—and we take this commitment seriously.
To propose a topic or express interest in presenting, please contact Dennis Shay at dpshay@gmail.com.