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PMINJ 2022 February SOCRA



Presentation


San Francisco Chapter SOCRA

Medical Device Regulations & Commercialization
and how Project Management and Clinical Research Support the Process!


09 Feb 2022
3:00 pm to 4:00 pm

Virtual

Abstract

The medical device industry continues to grow and undergo rapid changes. The global medical device market is estimated to reach $658 billion by 2028; the U.S. market is estimated at approximately 40% of the world market. Medical devices include products of all complexities, ranging from bandage strips and thermometers to in-vitro diagnostics, robotic surgical systems, orthopedic and other implants, life-sustaining devices, and much more. Clinical research is a key discipline supporting the entire medical device product lifecycle – pre-market through post-market to end of life. Project management has become a foundational skill for all functional groups involved in product lifecycle projects incorporating clinical research.

Objectives:
  • Understand the medical product lifecycle, how medical devices are defined and classified, and regulatory pathways to commercialization in the US & EU
  • Key roles & activities for clinical research throughout the product lifecycle
  • Understand how project management can be deployed throughout the product lifecycle to achieve product and organizational goals, including the integration of clinical research


Speaker:

speakerClaudia Campbell-Matland, PMP®, Chairperson, PMINJ Life Sciences LCI and Consultant & Managing Member, CNCM Consulting LLC

Claudia has 30+ years’ experience in the medical device industry managing a variety of business-critical programs/projects including new product development, Quality System remediations, postmarket support and functional department integrations. As an independent project management and quality consultant, she works with start-up companies to manage translation of their research into a compliant design & development process, and supports postmarket activities for small medical device companies with risk management and other quality system expertise.  Claudia also enjoys sharing her project management knowledge as a contract instructor for university continuing education departments. She launched Project Management Institute’s New Jersey Chapter’s (PMINJ) Life Sciences “LCI” (Local Community of Interest) in 2019, and leads its core team in developing events & content for Chapter members working and / or interested in the life sciences industry.


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Register Now

Registration through SOCRA
  • $0.00 - PMINJ Chapter members
  • RSVP to Geo Gaile (ggaile@immunetolerance.org) by 1/31/2022
  • Identify your PMINJ Chapter membership
  • Details to enable virtual attendance will be sent to all who register

PDP Information

Program Number: C020-20220209
Medical Device Regulations & Commercialization
and how Project Management and Clinical Research Support the Process!
Activity Sponsor: PMINJ Chapter (C020)
PDUs: - 1.0
Leadership - 0.0
Strategic - 0.0
Technical - 1.0

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