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  • Mitigating risks using outdated practices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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Instructor Profile:
Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, 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 Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont.

He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement and is Senior Member of IEEE. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more books Assurance Technologies Principles and Practices, and Safer Hospital Caret. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He has done seminars on Risk Management, Process Validation, Software Reliability, Software Safety, Design Control, and Corrective and Preventive Action (CAPA) System.
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