Practical Application of ISO14971: 2019 Risk Management for Medical Devices

1.5
RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 04 May 2023 (12:00 PM) - Thursday, 04 May 2023 (1:30 PM) Eastern Time (US & Canada)

This seminar will explain how to apply the latest ISO standard revision as it relates to risk management to design controls, process controls, and user training. The seminar will demonstrate how FMEA alone is inadequate as a tool for quantifying risk related to medical devices, leading to inefficient and ineffective practices that ultimately don’t control risk.


REGISTRATION FEES & DEADLINES

February 9, 2023 – April 4, 2023: Early Bird $150 Member | $175 Nonmember

April 5, 2023 – May 4, 2023: Regular $175 Member | $200 Nonmember


Learning Objectives

At the conclusion of this workshop, participants should be able to:

  • Identify the elements of an ISO14971 compliant risk management file.
  • Understand how to assess and quantify risks for evaluation and comparison purposes.
  • Understand how design controls, process controls, and user training are applicable to risk assessment, quantification, and reduction.
  • Understand how investing in a solid risk management file can support compliance with other medical device regulations.

Audience Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

Regulatory professionals, medical device program leaders, senior medical device engineers, risk managers, design quality assurance professionals, production quality assurance professionals.


Instructors:

Alex Saegert

Alex Saegert

Alex Saegert is an ASQ-certified Reliability Engineer (CRE) and Supplier Quality Professional (CSQP), and holder of a specialized ASQ credential in Risk Management. With 25 years' experience in diverse fields as medical device development and risk management, reliability and safety engineering of hydrogen fuel cells, alternative energy powertrains for cars, trucks, and locomotives, and in reliability and safety engineering in the nuclear power industry, he is licensed as a professional engineer in the provinces of Alberta, and British Columbia, Canada. He is the President of Saegert Solutions Inc., an engineering consulting firm specializing in helping companies navigate product development, to turn new technologies into products that are safe, effective, reliable, and ready.


Cancellations

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

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

 

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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