Special Considerations during Medical Device Design - Dos and Don'ts

Duration: 60 Minutes
In the past, the designer was in charge of everything that could go wrong in the product performance. Today product's manufacturing processes, supply chain controls, and product users have become disengaged in many companies: therefore most design engineers are far removed from many things going wrong. The most efficient way to prevent recalls is to identify as many potential problems as early as possible related to safety, reliability, durability, and efficacy using the best practices. This needs to be done before approving specifications.
Medical Device Designing
Instructor: Dev Raheja
Product ID: 500747

Why Should you Attend:
No person can capture all the requirements not even a team of intelligent cross functional members. This webinar will discuss about the structured methods with which a company can capture most of the requirements. Insufficient knowledge will lead to insufficient device performance. Therefore entire product development team should take advantage of this webinar.

Objectives of the Presentation:
Learning objectives of this webinar are:
  • Right things you must always do
  • Conducting Requirements Analysis to Identify Missing Requirements
  • Conducting Preliminary Hazard Analysis (PHA) to Assess Risks
  • Negative requirements Analysis for Worst Case Scenarios
  • Specification for Safety, Durability, and Reliability
  • Specification for User Interface and Usability
  • Specification for Maintainability
  • Designing for hazard-free maintenance
  • Specification for Prognostics
  • Specification for Safe Software
  • Mitigating risks using world class practices
  • Installation qualification, operational qualification
  • Performance qualification
  • Specification for Safety, Durability, and Reliability
  • Specification for User Interface and Usability
  • Designing to Forgive User Errors
  • Specification for Prognostics
  • Independent verification and validation
  • Wrong things you must avoid
  • Group Think process
  • Myopia of knowledge
  • Inefficient team management
  • Approving specifications without challenge
  • Mitigating risks using outdated practices
  • Accepting costly solutions
  • Insufficient control on residual risks
Who can Benefit:
  • All Engineering managers and Engineers
  • Entire QA staff
  • Entire Regulatory staff
  • Device Maintenance staff
  • Marketing staff
$375
Recorded Session for one participant
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
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  • 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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