Introduction to Software Validation for Medical Instrument Development

Robert (Bob) Uleski
Robert (Bob) Uleski
Wednesday, August 7, 2019
10:00 AM PDT | 01:00 PM EDT
60 Minutes

More Trainings by this Expert   Product Id : 502615

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
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This is an introduction to software validation for medical device development targeted to software developers, engineers, testers and managers. It covers simple and small projects to mid-size projects including development projects and manufacturing projects. It will be useful for new hires in any of these functions and for persons assigned to audit the validation results.

Why should you Attend: There are several key elements that need to be included in your instrument Validation and Verification efforts to ensure compliance with FDA and EU IVDR (In-Vitro Diagnostics Regulation). The new regulations have added many new requirements that translate to new deliverables your testing report must provide.

We will discuss the main elements software validation for Medical Instrument Development to deliver testing results complying with these regulations.

Areas Covered in the Session:

  • Software Development Lifecycle and how it relates to project phases
  • Regulatory and Compliance needs for each phase
  • How FDA design control guidance can be applied to waterfall development
  • Lifecycle and FDA guidance
  • Stress Testing approaches
  • Traceability and Design Reviews System, Unit, Integration testing level strategies
  • Defect tracking and managing

Who Will Benefit:
  • Software Managers
  • Software Engineers
  • Test Engineers
  • Quality Engineers
  • Quality Scientists
  • Regulatory Affairs Teams
  • Manufacturing Engineers

Speaker Profile
Robert (Bob) Uleski has developed and led projects over the past 40 years for 11 clinical chemistry systems, 5 immunoassay systems, 2 hematology automated analyzers, and 3 laboratory data management systems. He was chairman of the Connectivity Industry Consortium’s Device Messaging Layer committee and has been actively involved in the CLSI POCT1-A: Point of Care Connectivity and AUTO9-A: Remote Access to Clinical Devices from the Internet. He has served on the ASTM committees for Computerization of clinical data and Laboratory Interface Standards and been a member of the ANSI Healthcare Informatics planning panel. Most recently he was a program manager at Beckman Coulter Inc. and has also consulted on Optics, Software, and Software Validation. Currently he leads programs for IVDR and REACH remediation.

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