Product Release and Post-Marketing Requirements

At this point in the product development cycle, we will join with you in celebrating your hard work and your product's entry into the marketplace!

The cycle can begin all over again, and we are always ready to work with you on your next project!

In the U.S., Canada and Europe, after a product has obtained regulatory approval and is released on the market, there are ongoing requirements and regulations to fulfill. The following must coincide with one another and be conducted throughout the entire product life cycle:

  • Post-market surveillance studies
  • Risk management program

Quality and post-market surveillance systems must be in place to gather information about the performance of the device over the course of its entire lifecycle. As a result, the proper complaint, as well as inspection and tracking systems must be in place to gather data such as malfunctions and any serious injuries or deaths caused by use of the device.

Innovation is never finished. Your planning should include consideration of future versions of the device.