Tech Insider: Achieving Medical Device Software Compliance under IEC 62304
Thursday, May 24, 2012, 2:00 PM EDT / 11:00 AM PT / 18:00 GMT (Duration: 1 hour) === It’s not an option. If you have software in a medical device, it must have been developed using processes compliant with the IEC 62304 software life cycle standard. That much is clear, but what actually constitutes conforming to the regulation is not as concrete. The IEC 62304 standard merely states that the software development processes must be as good as, or better than, what is required in the IEC 62304. That leaves some room for interpretation and perhaps making the wrong choices, leaving you on the wrong side of “is as good as” and well behind where you need to be in bringing the device to market.
This webinar will discuss the software development activities that you need to include in your process and the deliverables you need to create to ensure that you meet the IEC 62304 standard with a minimum of headaches and a high level of employee compliance.
The following topics will be covered:
• An overview of IEC 62304
• Critical implementation issues
• Keys to a successful implementation
• How to reconcile an iterative software development approach with 62304