Introduction to Software Validation for Medical Instrument Development
In this webinar, we will discuss the main elements software validation for Medical Instrument Development to deliver testing results complying with these regulations.
March 30, 2020
10:00 AM PDT | 01:00 PM EDT
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Product Id : 502956
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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:
Who Will Benefit:
- 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
- Agile Lifecycle and FDA guidance
- Stress Testing approaches
- Traceability and Design Reviews
- System, Unit, Integration testing level strategies
- Defect tracking and managing
- Software Managers
- Software Engineers
- Test Engineers
- Quality Engineers
- Quality Scientists
- Regulatory Affairs teams
- Manufacturing engineers
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.