Medical device software can make or break a device. Badly developed, non-compliant software can compromise a device's safety and reliability. The goal is that upon completion of this pack of courses, you should understand how to create and maintain safe software for medical devices throughout their life cycles. In addition to this, you should also understand how IEC 62304 interlinks with other standards such as ISO 14971 and ISO 13485.

The courses include IEC 62304 requirements and explains risk based approach for Verification and Validation using protocols and GAMP. What if your software is not a product; how would you validation it? Well, this pack has answers to that.

Next, it takes you through a process of software validation giving you a complete overview of the imminent changes and their implications, using an innovative approach yet is based upon solid principles and proven practices. And finally, and importantly, the cyber attacks threaten medical devices and how the industry is currently responding to them. You will learn the many ways of preventing and mitigating the cybersecurity risk, and about the industry’s best practices that can help your company do the same.