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When is the right time to have a design freeze for a medical device?

The term "design freeze" is not a regulatory definition. It is a term that companies use to communicate the concept that the design should not be changed from that point forward in the design project. Agile projects involve continuous improvement and design changes, while traditional project management involves more formal stage/gate milestones. All medical device development projects are hybrid development projects, because the development process is iterative by necessity and the regulatory approvals required for clinical studies and commercial launch require a regulatory review (i.e., a stage-gate). In this live-streaming video, we will discuss when the right time is to have a design freeze and when more than one "freeze" is necessary. If you are interested in trying Streamyard for developing your own video content, please check out StreamYard: https://streamyard.com/pal/d/4790150438977536