Defect Management in SaMD — From Chaos to Control скачать в хорошем качестве

Defect Management in SaMD — From Chaos to Control

In this episode, we dive deep into one of the most underestimated — yet critical — topics in Software as a Medical Device (SaMD): Defect Management. What is a defect in regulated medical software? How is it different from a simple “bug”? When does a defect trigger CAPA, risk review, or even vigilance reporting? We explore: ✔ The fundamentals of compliant defect management ✔ The link between defects and risk management (ISO 14971) ✔ Handling post-market defects and patient safety implications ✔ Managing SOUP and third-party component defects ✔ Traceability across versions and agile environments ✔ Common audit findings and compliance pitfalls You’ll also learn how defect trend analysis can feed into CAPA, management review, and continuous improvement — and how an eQMS like SmartEye can support automation without losing control. If you work in QA, RA, software development, or lead a SaMD startup, this episode is for you. ----------------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video anindya linkedin:   / anindyamookerjea   ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance