I agree with previously made points. Design changes can affect several parts of the product and can create several moving parts that the project manager and team need to be aware of. First I would agree with merzkrashed is you need to evaluate the design change, if it is necessary or if there are other options. Then you’d need to consider what those options are and what they affect, so the schedule, budget, registrations, etc. I agree with f-dot, I think keeping in mind about your vendor or your partner’s position is also important, so how is this design change occurring, who is supplying/implementing the change, does the current vendor have the capability/equipment for this change and if not figuring out a new supplier, and what other parts does it affect. Then these changes will need to have validation checks to ensure the change is beneficial before approving and accepting the change. So this is where I would agree with aij5, revalidating for efficacy/accuracy, sterility, packaging/environmental testing, biocompatibility, etc. All of these extra tests need to be considered in the schedule and budget. Documents also must be updated to reflect any of the changes being made for traceability for not only the company itself, but for auditing purposes as well.