Safety in Binary?
Channel: DocuRegs
Date: 2024-01-22

𝗦𝗮𝗳𝗲𝘁𝘆 𝗶𝗻 𝗕𝗶𝗻𝗮𝗿𝘆?
Understanding this IEC standard for the safety of your medical devices.

This video takes a deep dive into the key elements of the standard, providing a clear and practical roadmap for compliance.

In this video, you will:

1. Gain a clear overview of IEC 62304 and its objectives.

2. Explore the three software classification levels and their implications.

3. Learn about the core principles of risk management in software development.

4. Uncover the essential development processes and their requirements.

5. Receive valuable insights on documentation and verification activities.

This video is ideal for:

Medical device software developers and engineers
Quality assurance and regulatory professionals
Project managers and product owners involved in medical device software development
Anyone seeking an understanding of IEC 62304

𝐖𝐚𝐭𝐜𝐡 𝐭𝐡𝐞 𝐯𝐢𝐝𝐞𝐨 𝐚𝐧𝐝 𝐬𝐡𝐚𝐫𝐞 𝐭𝐡𝐞 𝐤𝐧𝐨𝐰𝐥𝐞𝐝𝐠𝐞 𝐰𝐢𝐭𝐡 𝐨𝐮𝐫 𝐜𝐨𝐦𝐦𝐮𝐧𝐢𝐭𝐲.

DocuRegs
"𝐁𝐫𝐢𝐝𝐠𝐢𝐧𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲, 𝐚𝐧𝐝 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠." 𝐀 𝟑𝟔𝟎-𝐝𝐞𝐠𝐫𝐞𝐞 𝐩𝐞𝐫𝐬𝐩𝐞𝐜𝐭𝐢𝐯𝐞.

#IEC62304#medicaldevicesoftware#softwaredevelopment#riskmanagement#regulatorycompliance#IEC60601