This webinar will discuss regulatory requirements for the medical device software development process and how the documentation needed for MDD technical files and for FDA submission can be developed as part of that process.
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.
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
Course Provider
Tim Stein,
