ELM-156-03

An Overview of the Medical Device Product Life Cycle

Med Dev Product Life Cycle

As mentioned, ‘validation’ covers a host of efforts.  

There are validation aspects to address in each of the product life blocks such as:

  • Planning
  • R&D
  • Production
  • And Post-Market

Which includes deployment, service, upgrades, and through to the retirement phase. 

But there are also validation aspects to consider for all the support processes too such as:

  • Quality System Activities 
  • Configuration Management
  • Purchasing 
  • Document Control
  • And Calibration etc

As you can see, validation is a continuous process that spans a large portion of the entire manufacturing process.

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group