When the Standard Doesn't Fit: How to test using a guidance vs. a standard
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Presenter: Mike Silverman, Founder and Managing Partner, Ops a la Carte
Reliability test plans are often generic or blindly following industry standards. Test plans must be tailored to fit customer use profiles. IEC 60601 Rev 3 requires that your testing be driven from your risk documents. This is true for all medical products but especially true for implantables. Implantables have a tricky use environment – relatively stable temperature and low vibration but potentially corrosive environment. In this presentation we will discuss how to write a reliability test plan and what areas to consider.
- IEC 60601-3
- Implantable reliability test plan
- Highly Accelerated Life Test (HALT)
- Reliability Demonstration Test (RDT)
- Corrosion Testing
- Risk Analysis - ISO14971
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ABOUT THE PRESENTER
Mike Silverman, Founder and Managing Partner, Ops a la Carte
Mike is founder and managing partner at Ops A La Carte, a Professional Consulting Company that has an intense focus on helping customers with end-to-end reliability. Mike has over 25 years experience in reliability engineering, reliability management and reliability training. He is an experienced leader in reliability improvement through analysis and testing. Through Ops A La Carte, Mike has had extensive experience as a consultant to high-tech companies, and has consulted for over 500 companies in over 100 different industries in most of the United States and 15 countries around the world. A few of the main industries are telecommunications, networking, medical, semiconductor equipment, consumer electronics, power, energy, and defense electronics. Mike is an expert in accelerated reliability techniques and owns HALT and HASS Labs, one of the oldest and most experienced reliability labs in the world. Mike has recently completed his first book on reliability entitled "How Reliable Is Your Product: 50 Ways to Improve Product Reliability". The book was published December, 2010. Mike has authored and published 25 papers on reliability techniques and has presented these around the world including Canada, China, Germany, Japan, Korea, Singapore, Taiwan, and the USA. He has also developed and currently teaches over 30 courses on reliability techniques.
Mike has a BS degree in Electrical and Computer Engineering from the University of Colorado at Boulder, and is a Certified Reliability Engineer (CRE) through American Society for Quality (ASQ). Mike is a member of ASQ, IEEE, Stanford PRN, PRG, SME, ASME, PATCA, and IEEE Consulting Society. Mike is currently the IEEE Reliability Society Santa Clara Valley Chapter Chair.
Medical device design and manufacturing professionals are always welcome and eligible for free admission to the Supplier Showcase and conference. Unqualified registrants will be charged a $95.00 admission fee. The complete list of admission policies can be viewed here. |
