Managing the Software Development Life Cycle to Produce Regulatory Documentation (for Medical Devices)

Why Should You Attend:

This webinar will cover the software development process and deliverable requirements of IEC 62304, “Medical Device Software – Software Life Cycle Processes.” It will describe a software development process that integrates the development of needed documentation with development, rather than trying to reverse engineer it.

This session will help both software developers and regulatory professionals if they understand what is required for submissions when the medical device contains software. And, if you outsource software development, it will help you manage the work performed by the developer so that you don’t have to reverse engineer the documentation by having someone read the code.

Areas Covered in the Webinar:

• An overview of IEC 62304 requirements for software development processes
• Software development deliverables that are part of the medical device technical file
• FDA documentation required for premarket submissions for products containing software (IDE, 510k, PMA)
• The alignment of IEC 62304 deliverables with requirements for the content of FDA submissions
• How to make sure that outsourced software developers prepare the needed documentation
• Questions and answers

Free Handouts:

• Alignment of IEC 62304 Deliverables with Design Control Requirements
• Alignment of IEC 62304 Deliverables with Requirements for FDA Submissions for Devices Containing Software
• A list of the software development procedures needed by the company and the development vendor

Who Will Benefit:

• Software engineers who want to / need to understand what the regulatory requirements are for the development of medical device software
• Regulatory affairs professionals who need to understand the software engineering process and how the required documentation fits within it
• Engineering management and project managers who need to understand what needs to be done for software development for a medical device so that they can estimate staffing needs and timelines

Instructor Profile:

Tim Stein, is the President and CEO of Business Performance Associates, Inc., a consulting firm located in Cupertino, California, that he founded in 1994. Tim’s has provided service to over 95 clients in software development processes, quality systems, and computer system validations. Tim also served as the Director of Software Validation and Quality Assurance at Genomic Health, Inc. (GHI).

For the past few years, Tim has focused on IEC 62304 gap analyses and providing leadership in establishing compliant software development processes, and reviewing and helping companies prepare documentation for FDA submissions and technical files.

Tim has given 40 public presentations over the past decade. He is a Fellow of the American Society for Quality and a member of both the Medical Device and Software Quality Divisions. Tim holds a Ph.D. in organizational psychology.

He is the author of a hands-on compendium for computer system validation, The Computer System Risk Management and Validation Lifecycle, Paton Press, 2006.

Topic Background:

The preparation on regulatory submissions and technical files has to be effective and efficient. All medical device companies are under pressure for the rapid development of products and quick preparation of technical files and submissions. There isn’t time for Regulatory to try to create, or rewrite, all of the software documentation after the software is coded and tested. The situation is even worse when software development is outsourced and neither those responsible for outsourcing it, nor those responsible for developing it, understand the regulatory requirements for software documentation.

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