Agenda:
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Understanding IEC62304: Learn the fundamentals of this vital standard, which defines the Software Development Life Cycle (SDLC) for medical devices.
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The Importance of Compliance: Discover why adhering to IEC62304 is needed for selling medical devices, as it’s harmonized with key regulations and recognized by global authorities like the FDA.
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Principles for Success: Uncover the main principles that guide successful medical software development under IEC62304, from requirement gathering to risk management, design, and traceability.
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The SDLC Process: Get a high-level overview of the Software Development Life Cycle process as defined by IEC62304.
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Interactive Q&A Session: Engage with industry experts during a live Q&A session to clarify your understanding of IEC62304 and its applications.
Event details:
- Date: October 2nd, 2024
- Time: 10 AM EDT / 4 PM CEST
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Why should you attend?
This webinar is essential for software engineers, compliance officers, quality assurance professionals, project managers, product managers, and product owners involved in the medical device industry. If you're looking to ensure your software meets rigorous regulatory standards while maintaining the highest quality, this session is for you.
Save the Date for Part 2
Join us again for Part 2 on October 17th at 10 AM ET, where we will demonstrate how to apply IEC62304 within SpiraPlan. You’ll see how to manage key artifacts—such as requirements, tasks, releases, tests, and traceability—in a real-world medical system project.
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.