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Navigating the Maze of IEC 62304: A Pure Global Masterclass on Medical Device Software Lifecycle and Global Compliance
In this episode of MedTech Global Insights, we demystify IEC 62304, the international standard for medical device software lifecycle processes. We break down the essential requirements that every MedTech innovator needs to know, from initial planning and risk-based safety classification to rigorous testing and post-market maintenance.
This is not just a theoretical overview. We provide practical insights and real-world examples to help you understand how to build a compliant and safe software product. Learn how to avoid common pitfalls that can lead to costly delays, regulatory rejections, and patient safety risks, ensuring a smoother path to global market access.
A prominent startup developed a groundbreaking AI diagnostic tool. They focused heavily on the algorithm's performance but maintained minimal documentation for their software development process, viewing it as a formality. During their EU MDR audit, the Notified Body found their risk management file and verification records for their Class C software completely inadequate. The result was a major non-conformity, forcing a six-month project delay to retrospectively build the entire technical documentation, which jeopardized their funding and market entry.
In This Episode, We Unpack:
1. What is the single most important factor in determining your software's safety class under IEC 62304?
2. How can a poorly written requirement at the start of your project lead to a complete regulatory rejection?
3. Why is your software architecture not just a technical issue, but a critical compliance checkpoint for auditors?
4. What is the crucial difference between software verification and validation, and why is this the most scrutinized part of a submission?
5. Does your responsibility under IEC 62304 end once your software is released to the market?
6. How can a flawed bug-fixing process trigger a full-scale product recall?
7. What are the key documentation mistakes that startups commonly make when first implementing IEC 62304?
Contact us for more information at [email protected] or visit https://pureglobal.com/.
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By Ran ChenIn this episode of MedTech Global Insights, we demystify IEC 62304, the international standard for medical device software lifecycle processes. We break down the essential requirements that every MedTech innovator needs to know, from initial planning and risk-based safety classification to rigorous testing and post-market maintenance.
This is not just a theoretical overview. We provide practical insights and real-world examples to help you understand how to build a compliant and safe software product. Learn how to avoid common pitfalls that can lead to costly delays, regulatory rejections, and patient safety risks, ensuring a smoother path to global market access.
A prominent startup developed a groundbreaking AI diagnostic tool. They focused heavily on the algorithm's performance but maintained minimal documentation for their software development process, viewing it as a formality. During their EU MDR audit, the Notified Body found their risk management file and verification records for their Class C software completely inadequate. The result was a major non-conformity, forcing a six-month project delay to retrospectively build the entire technical documentation, which jeopardized their funding and market entry.
In This Episode, We Unpack:
1. What is the single most important factor in determining your software's safety class under IEC 62304?
2. How can a poorly written requirement at the start of your project lead to a complete regulatory rejection?
3. Why is your software architecture not just a technical issue, but a critical compliance checkpoint for auditors?
4. What is the crucial difference between software verification and validation, and why is this the most scrutinized part of a submission?
5. Does your responsibility under IEC 62304 end once your software is released to the market?
6. How can a flawed bug-fixing process trigger a full-scale product recall?
7. What are the key documentation mistakes that startups commonly make when first implementing IEC 62304?
Contact us for more information at [email protected] or visit https://pureglobal.com/.