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.
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[@MedicalDeviceAcademy]

One of the comments asked after we ended the session was: "Could you explain the order of how the testing goes?" The order of testing is different for each product--even when you are making a new version of an existing product. The reason for this is usually based upon simple things like logistics (e.g., when are the samples going to be available). If you want to know more about testing plans, please see our webinar on this: medicaldeviceacademy.com/test-plan/

[@assassinsylvia8117]

Thank you for answering my question!