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.
