Special Considerations during Medical Device Design - Dos and Don'ts
Duration : 60 Minutes
Dev Raheja,
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologi Read more
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.
Course Objectives:
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.
Course Outline:
• 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• Mitigating risks using outdated practices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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• All Engineering managers and Engineers
• Entire QA staff
• Entire Regulatory staff
• Device Maintenance staff
• Marketing staff
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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