Whether you're new to IEC62304 or building on your knowledge from Part 1, this practical demonstration will show you how to implement the standard effectively in your software development processes.
Agenda:
- IEC62304 Recap: A quick refresher on the fundamentals of this crucial standard for medical device software development.
- Product Structure: Understand how to define and structure your medical device projects in SpiraPlan.
- Product-to-SpiraPlan Mapping: See how to map your medical system’s components directly into SpiraPlan’s project structure.
- Project Artifacts Relationship: Learn how requirements, tasks, releases, and tests interact within the SpiraPlan ecosystem.
- Live Demo in SpiraPlan: Watch a live demonstration of how SpiraPlan handles IEC62304 compliance, including traceability between project artifacts.
- Q&A Session: Engage with our experts in a live Q&A to clarify how you can apply these practices in your own projects.
Event Details:
- Date: October 17th, 2024
- Time: 10 AM EDT / 4 PM CET
Register Now!
Why should you attend?
This session is designed for software engineers, compliance officers, quality assurance professionals, project managers, product managers, and product owners working in the medical device industry. If you're looking for practical insights into applying IEC62304 and ensuring traceability, join us for this live demo to see how SpiraPlan can support your regulatory needs.
Meet the Speakers
Vladimir Plotkin is the Director and Safety-Critical Software Consultant at Inmarsys Limited, a company with extensive experience in Safety-Critical (Medical, Automotive and Aerospace) areas. Vladimir is based in Britain and is helping Medical Companies and Startups to navigate the sea of Medical Software compliance and development with ease. Vladimir holds a MSc degree in Computer Science from the Minsk RadioEngineering Institute.
Inmarsys primary goal is to assist their clients to accelerate development of their Medical products and, as a result, to help people to get access to better healthcare.
Dr. Sriram Rajagopalan is the Global Lead on Training and Agile Transformation at Inflectra. Sriram designs and orchestrates the training curriculum for Inflectra’s platform, along with delivering business process consulting for strategic companies in multiple industries using Inflectra’s products. In addition, Sriram serves as an Assistant Teaching Professor at Northeastern University, designing and delivering courses on Leadership, Project Management, Agile, and Information Technology. Sriram holds a BS in Electronics and Communication Engineering from the University of Madras in India, an MS in Computer Engineering from Wayne State University, Michigan, an MBA in Management from Concordia University, Wisconsin, and a Ph.D. in Organization and Management from Capella University, Minnesota.