How to evolve from a “software developer” to a “software development partner for medical device software”

1 April, 2019

Often software development companies do not know about the regulatory requirements for medical device software, especially when it comes to the maintenance requirements in the post-market phase. A sole software developer is often not prepared to support a medical device manufacturer throughout the whole life cycle of the medical device containing software.

Typical pitfalls that you want to avoid when you plan to develop medical device software:

  • Don’t think about the project as an isolated development project. You need to consider interrelations with regulatory experts, experts with medical background and different other stakeholders that support the software system once it is used live.
  • Think about regulatory requirements and risks related to software development in the very beginning. They are important inputs to your software design and architecture.
  • Employ considerate software developers who want to think about a robust software architecture before start programming and who document their decisions and source code.
  • Don’t underestimate the maintenance effort once the medical device software is live. Changing a medical device software requires a sound impact analysis and should be understood as a project itself.

To avoid the failures of such projects and frustrations on both ends, software development companies need to adapt and become software development partners. They need to understand the needs of medical device companies and be prepared for long-lasting relations.

knoell Germany GmbH can help you to become a software development partner by providing skilled expertise specialized in medical device related software.


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