Software Development Life Cycle (SDLC) is the most important element of a Software as a Medical Device (SaMD)Quality Management System (QMS). The right model should be identified considering:

• The uniqueness of your SaMD and its intended use
• The kind that will work for your team 
• The level of information to be made available at each stage to proceed 
• The time & cost constraints with which you have to work to reach design freeze 

Some practical challenges –

Defining all requirements upfront 

Defining all the specifications and requirements at the start of the development can be difficult due to the nature of the product, there also might not be sufficient information to allow robust benchmarking. 

Accountability of product quality 

While the involvement of a QA team is good, the product development team should take the accountability of quality, so quality by design is truly achieved. 

Integrating user feedback

It can be counterproductive when the product gets seen by the users only at the end. The approach of incorporating user feedback early on goes a long way.  

A quick comparison of different life cycles –