Reliability Basics –

All QA Professionals Need to Understand this Discipline

Wednesday, April 24, 2019 7:00 - 9:00 PM

Topic: Back to Basics - The Basics of Product Reliability

§820.30(g) Design Validation: Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.

ABSTRACT:

As medical devices continue along a path of increased complexity, greater sophistication is required for a successful qualification program. This roundtable is intended to discuss best practices for programs aimed at improving the reliability and performance of medical devices. Topics which will be covered include:

• Reliability Basics – How does reliability fit into the Medical Device Design Process

• Review of reliability standards relevant to implantable medical electronic devices

• Example test regimens for accelerated life testing for medical products (e.g. HASS/HALT)

• Developing an implant retrieval program to analyze early field failures

• Techniques for root cause failure analysis to understand early test and field failures

• How reliability fits into the Design Control process

• Weaving together FMEAs, early field failures, and accelerated life testing

• Bridging industries – Best practices from Consumer Electronics products translated into Medical Devices

• Techniques for estimating the effective lifetime of the device: Simulation and Bayesian methods

FEATURED SPEAKERS:

Scott Lovald is a Managing Engineer in Exponent’s Biomedical Engineering Practices. He provides scientific and engineering consultation on design evaluation, performance optimization, and failure analysis of medical devices, mechanical systems, and structural materials. Prior to Exponent, Dr. Lovald worked at multiple medical device startups focused on novel orthopedic device development and clinical outcomes research. He received his Ph.D. in Mechanical Engineering from the University of New Mexico in 2008.

Shilpi Panzer is a Senior Managing Engineer in Exponent’s Electrical Engineering and Computer Science Practice. Her consulting work is focused on failure analysis and risk assessment of consumer electronics, fire inspection, replication testing of thermal events, reliability testing of consumer products, environmental testing of materials and product prototypes, electrical micro probing, and PCBA/component failure. She received her Ph.D. in Electrical Engineering from Stanford University in 2015.

Moderator:

Gary Seeger, Vice President, Stellartech Research Corp., BS Physics, Harvey Mudd College, CQE, CRE.

Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035

Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.

Email: To be added to or removed from our email list, contact George Marcel (gjmarcel@gmail.com).

Registration Link: http://ncdgapr019.eventbrite.com

ONLY Credit Card accepted at door via Eventbrite

Questions: For information about this session, contact Anesh Tilwani (Anesh.tilwani@gmail.com).

Formal discussion and questions will end between 8:30 - 8:40 pm to allow time for networking.

Materials: Presentation & workshop sheets provided for onsite attendees only. Please limit distribution to attendees: personal professional use only.

Webinar Remote Access (no cost):

https://attendee.gotowebinar.com/rt/8290285084177151234