Testing Medical Devices for Efficiency and Efficacy

Duration: 60 Minutes
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.
Medical Device Testing
Instructor: Dev Raheja
Product ID: 500250

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:
Having your medical devices tested and calibrated decreases maintenance charges, downtime and significantly improves efficiency, allowing medical equipment and their component parts to work longer at a minimal increase to costs. This webinar will surely provide an insight on full range of performance testing including functionality, safety, energy efficiency, durability, reliability, and more apart from delivering diverse knowledge on performance tests to many FDA Guidance Documents, AAMI and ANSI standards.

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
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Flash Drive
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How it works
Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dev Raheja, MS,CSP, author of the books Safer Hospital Care and Preventing Medical Device Recalls, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for variety of systems. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management and the online faculty at University of Maryland where he teaches courses on Reliability. He is a Founding Fellow of American College of Healthcare Trustees and a member of American College of Healthcare Executives, He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners.

He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital. He helped them in providing 24/7 access to family members of patients and reduced the number of alarms for nurses so they recognize critical patient needs early.
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