50 2014 - Testing Medical Devices for Efficiency and Efficacy

Instructor: Dev Raheja
Description:
Testing for safety, reliability, and durability are the most meaningful tests for adequacy of product, efficient performance (no down time, no recalls), and for the highest value (gaining more loyal customers). Unfortunately such knowledge is very thin in the literature. This webinar is based on consultant’s 30 years hands on experience with this knowledge.
The FDA reviews summary of tests in the 510(k) summaries as well as when an investigation takes place in the event of an adverse event. Good tests also discover new risks, design mistakes and manufacturing mistakes. Therefore the safety, reliability, and durability tests are the key to proactive product management.
Why Should you Attend:
The most important reason for attending is because this knowledge is not easily available. Yet this knowledge is critical to the business survival. Absence of safety, reliability, or durability is a sure way to loose sales.
Objectives of the Presentation:
Use-Related Hazards
Use Scenarios Resulting in Hazards
Test Protocols
Designing reliability tests for design
Designing reliability tests for production
Designing lifetime and performance durability tests
Calculation of Estimated Lifetimes
For mechanical/electrical devices
For fluids in the products
FDA guidance for reliability testing on a device
Device User Interface testing
Verification and Validation
Calculation of Estimated Lifetimes
Software/hardware integration testing
Who can Benefit:
Design Engineers and Managers
R&D Engineers and Managers
QA Engineers and Managers
Regulatory Personnel
Manufacturing Engineers and Managers
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