Quality management systems for neural engineering: principles and practices

Vaclav Kremen, Fawad Jamshed, Brinkmann Benjamin, Gregory A. Worrel, Philip Starr, Kent Leyde, Tim Denison

Research output: Chapter in Book/Report/Conference proceedingChapter


Regulatory bodies outline a very specific set of requirements that needs to be fulfilled for developing a medical device. Most of the medical devices require some form of a quality management system (QMS) to demonstrate how regulatory requirements are fulfilled.

To produce regulated, effective, efficient, and safe medical devices, a structured and well-defined set of procedures and rules needs to be followed and documented. Such rules should cover all aspects of the realization of a medical device.

This chapter lists the importance of the QMS in medical devices and the motivation to learn about them. The background of the QMS is laid down with help of references to key regulations and international references standards. Typical QMS elements are listed and further explained with the help of a case study of the Mayo Clinic EPAD system. This helps in softening the learning curve and helping teams better understand, implement, and apply QMS concepts to their advantage.
Original languageEnglish
Title of host publicationHandbook of Neuroengineering
EditorsNitish V. Thakor
Place of PublicationCham, Switzerland
Number of pages45
ISBN (Electronic)9789811528484
Publication statusPublished - 19 Oct 2022


  • quality management system
  • medical devices
  • risk analysis
  • risk mitigation
  • deep brain stimulation
  • neural engineering
  • closed-loop
  • neural implants


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