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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from June 2020.
When you're involved
with the regulatory requirements in the medical device industry, deadlines are
usually on the horizon. Join speakers from Reed Tech Life Sciences and
NiceLabel for an interactive webcast focused on two compliance areas they are
monitoring closely. The webcast will review what you need to know and do right
now to address the following:
• US FDA September
24, 2020 -- Class I devices and unclassified devices are required to be labeled
with UDI and have UDI data reported to GUDID. Have you verified all products in
your portfolio are currently compliant? Can you claim any of the Class I UDI
• EU MDR May 26,
2021 -- Due to impacts of the COVID-19 pandemic, the Date of Application (DoA)
for the EU Medical Device Regulation (MDR) has been postponed for one year
until May 2021. This MDR postponement along with the delay of the EUDAMED
launch until May 2022 have triggered many industry questions regarding the
implementation timing of MDR requirements and the interim use of legacy Medical
Device Directive procedures. Do you have uncertainty on EU medical device
registration and labeling requirements or timing?
The presenters will
review and provide clarity on currently posted guidance and answer questions
from attendees. The webcast will focus specifically on:
• The US FDA label
and data reporting requirements due 24 September 2020 for Class I devices
• The EU MDR label
and data reporting requirements due 26 May 2021
• The differences
and similarities of FDA and EU Unique Device Identification (UDI)
• How the COVID-19
driven shift to remote, cloud-based labeling eases compliance
• The advantages of
a comprehensive, global strategy for UDI and labeling compliance
Content is introductory in nature and requires no requisite knowledge or
experience to grasp concepts and related
educational activities are meant to establish a foundation of knowledge and/or
competence that will be
expanded upon in
practice or in higher level activities.
Upon conclusion of
the program, you will be able to:
• The US FDA label
and data reporting requirements due Sep 24, 2020 for Class I devices
• The EU MDR label
and data reporting requirements due May 26, 2021
Who Should Attend
• Unique Device
Identification Team Members
• Product Labeling
• Global Strategy
• Product Managers
and Business Analysts
Operations, and Supply Chain Leaders
• Quality Leaders
• Medical Device IT
Sr. Manager, Information Solutions Life Sciences, Reed Tech
Gary Saner is a
subject matter expert on medical device unique device identification and other
structured content reporting to regulatory agencies and commercial
organizations. He has over 30 years of experience in software development,
process management and data administration with the last 15 years focused on
the life sciences industry. With an understating of regulations, business
requirements and systems, he has helped shape and implement solutions at Reed
Tech for data management, validation and processing of drug labeling and
medical device unique device identification content. He serves as Co-Chair of
the industry’s Structured Product Labeling Technical Team and on the Advisory
Board of the Medical Devices Group.
Lee Patty, VP
& GM, NiceLabel
Lee Patty is VP and
General Manager at NiceLabel Americas where he oversees the company’s sales,
project delivery and operations in the Americas. Over his 25-year career, Lee
has worked with life sciences companies to improve their labeling process while
meeting industry regulatory requirements. Prior to NiceLabel, he co-founded
Niceware International, LLC, a NiceLabel distributor, where he was responsible
for marketing, healthcare product development and professional services.
NiceLabel acquired Niceware in 2013 and added Lee to the global executive team.
Lee has 25 years of AIDC industry experience.