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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
February 9, 2023 – April 4, 2023: Early Bird $150 Member | $175 Nonmember
April 5, 2023 – May 4, 2023: Regular $175 Member | $200 Nonmember
At the conclusion of this workshop, participants should be able to:
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.
Regulatory professionals, medical device program leaders, senior medical device engineers, risk managers, design quality assurance professionals, production quality assurance professionals.
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.
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 email@example.com. 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 firstname.lastname@example.org with the event title, name of the original registrant and the contact information for the new attendee.
A certificate of attendance can be downloaded
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following the event.
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