Total Product Life Cycle : Product Launch Phase
Once a device has received marketing authorization from the FDA, there are additional steps the sponsor must take in preparing to make the device available for public use. This includes finalizing the “device master record” (DMR), which includes all the records relating to the procedures and specifications for a finished device. It is often recommended that a sponsor work on finalizing the DMR in parallel with the development cycle to make the process of bringing the device to market once authorized as seamless as possible.
Additional steps the sponsor must take during the product launch phase include setting up a network for distributing the product to providers and the public, developing marketing materials, and registering with the FDA.
Read about the Total Product Life Cycle here »