Ensure Your MDR Program is State of the Art

1.5
RAC Credits
Virtual Programs Virtual Programs
Tuesday, 24 May 2022 (12:00 PM) - Tuesday, 24 May 2022 (1:30 PM) Eastern Time (US & Canada)

While MDR does not define state of the art, it discusses state of the art in eleven instances. Further, though MEDDEV 2.7.1/4 also does not define the term, the guidance discusses state of the art 39 times.

Unlike MDR, ISO 14971:2019 did formally define state of the art. This webcast will discuss how this definition further rolls into the definition of standard of care.

The presentation will also cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.


Learning Objectives

After this program, participants will:
  • Understand the formal definition of state of the art and how that affects the interpretation of dozens of references throughout a myriad of regulatory documents.
  • Understand the lifecycle of state of the art and impact on standard of care.
  • Understand impacts on all aspects of MDR CE-marked product documentation.

Registration Fees & Deadlines

Free


Who Should Attend?

This webcast is best suited for regulatory professionals involved in the preparation of documentation throughout the product lifecycle from early design and development to postmarket surveillance and ongoing risk management activities. These concepts will have a far-reaching impact on the proper content of these living documents.


Instructors:

Michelle Lott

Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She and her team supported over a hundred companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services – and grief counseling(!), because dealing with regulators can be emotionally draining. Her clients delegate those things to her, so they can focus on winning in the marketplace. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP), holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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