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Stage – ID5: Distribute the Product

This stage includes not only manufacture, quality control, packaging and distribution throughout the product's lifecycle, but also legal, financial, business development, training and other support activities.

Select a task name below for more information

Task Overview

The first production run of your product is critical to the product launch, as marketing, efficacy, user acceptance and regulatory needs are all dependent upon it.

What you need to do:

  • If your product is an implantable or therapeutic device, then the initial manufacturing must use a validated production route to produce first clinical use prototypes for studies of clinical safety and efficacy. This is likely to be required before marketing approval is given.
  • If necessary or sensible, have your quality systems audited by a Notified Body (e.g. BSI) to enable your product to be CE-marked. A common way of making sure products are meeting user and regulatory needs is through statistical process control (SPC) of critical measurements and key production processes, such as throughput, waste and energy. You will soon know whether your processes are properly under control.
  • Be aware that some medical devices may require complex instrumentation that also needs to be tested for clinical effectiveness, and then made in sufficient quantity to support the product launch. This can place serious demands on the capacity and financial resources of a small company.