Chapter 11 - Medical Device Standards and Design Controls

Abstract

This chapter presents medical device standards and their impact on the medical device design process. Although standards have been presented in multiple previous chapters in the text, this chapter explores the various types of standards and standards organizations, the mechanisms by which standards are written, approved, disseminated, and almost universally adopted. Technical standards are especially critical in health care because regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA ), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, will only clear healthcare products for clinical use that satisfy a specific set of standards related to technology being developed. Most standards are created by one or more standard development organizations (SDOs), which number over 100. In addition to technical standards, there are those that formalize the design processes. One primary standard for health care is published by the International Organization for Standardization (ISO). Specifically, ISO 13485 (Medical devices—Quality management systems—Requirements for regulatory purposes), is a primary quality systems standard for medical device companies and includes design controls that impact how medical devices are designed and developed. The chapter explains how design controls formalize the design process and concludes with an example where standards guide a calibration test needed for accuracy.