Conducting a Software Validation of Medical Device to Meet FDA Requirements

Product Id : FDA46
Instructor : Edwin Waldbusser
Jan 18, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Download Conference Material

Download Here (Password Needed)

Overview

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is not a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Why Should you Attend:

Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements, analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product.

Objectives of the Presentation:

  • Software validation more than testing
  • Requirements traceability
  • Risk analysis
  • Unit, integration and system testing
  • Algorithm validation
  • Challenges to the software
  • Configuration management/ design control

Session Highlights Points:-

  • How to properly plan Verification and Validation activities.
  • Verification & Validation testing throughout the product life cycle.
  • How to determine sample sizes needed for testing.
  • What is appropriate objective evidence.
  • How to perform regression analysis.
  • What is meant by Production Equivalence.
  • How do we validate test methods.
  • Special considerations for software based products.

Who will Benefit;

  • Software Developers
  • Software Engineers
  • IT Personnel
  • Device Development Managers
  • Systems engineers responsible for developing requirements
  • Test Engineers
  • Quality System auditors
  • Quality System auditors

Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.


Available Options