Failure Analysis During the Design Process of Medical Devices

Instructor: Marta L Villarraga
Product ID: 700449
Training Level: Intermediate

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This FMEA training for medical device will provide insight on the importance of failure analysis during the design process and will provide an overview of FMEA practices.

To enhance the understanding of the principles of failure modes and effects analysis, participants of this webinar will also complete a mock FMEA for a design of a hypothetical electrically active eye prosthesis. Analysis of failure modes of this example will illustrate how, even in a device with very diverse functional blocks, FMEA is an effective tool for ranking risk.

Areas Covered in the seminar:

  • What is FMEA?
  • How does FMEA fit within the design process?
  • What kinds of FMEA exist?
  • Who needs to participate in an FMEA
  • How does FMEA fit within risk management?

Who will benefit:

This webinar will provide insight on the importance of failure analysis during the design processand will provide an overview of FMEA practices. A hypothetical example will be used to understand its practice as part of design verification. Companies who will benefit are from the medical device and combination product fields. The employees who will benefit include:

  • Engineering staff in design and manufacturing
  • Health professionals who interface with physician or patient users
  • QA managers and personnel

Instructor Profile:

Marta L. Villarraga, Ph.D. is a Principal Engineer at Exponent, Inc, a scientific and engineering consulting firm. Dr. Villarraga concentrates her practice in failure analysis of medical devices in the areas of product liability, intellectual property, regulatory compliance, quality control and manufacturing compliance. She has assisted companies with root cause analyses prior to a recall or as part of the investigation following a recall being announced. Dr. Villarraga is also a reviewer for various scientific journals. She has also published a number of scientific articles and frequently presents at national conferences. She recently contributed to various chapters in the book "Bringing your Medical Device to Market," including one on medical device recalls. She also holds adjunct faculty appointments at various local and regional universities where she often lectures.

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Medical Device Summit 2018

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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