Analysis of Commercial Electronic Quality Management Systems for Medical Devices

Abstract

Medical Devices play an essential role in delivering healthcare in home and hospital settings. Medical Devices are regulated in Europe and the United States to ensure effective and safe usage of devices and prevent problems associated with recalls and adverse events. Regulatory authorities require that devices are registered and regulated before being made commercially available to patients and healthcare providers. A Quality Management System is a cornerstone regulatory requirement that manufacturers create and have certified to obtain marketing approval in Europe, the United States, and four other regions participating in the medical device single audit program. This thesis uses an instrumental case study approach to understand quality requirements and quality system software selection for medical devices for a case company. Furthermore, the thesis investigates the benefits, costs, and functions of commercial electronic quality management systems. The objective is to present a comprehensive and practical overview of quality management, information management, validation requirements for software, followed by an example of a commercial system that most closely aligns with the case company User Requirements.

The materials and methods used to analyze the solutions include information gathering and a sample electronic quality management system that implements quality artifacts for a medical device with hardware, software, and service components. The case company's product was generalized to apply to any medical device. The focus is on demonstrating the requirements and features a quality system needs to support. As part of the thesis investigation, an ISO 13485 certified quality system was used as a model for creating a sample electronic quality management system. Outcomes of this thesis establish that a quality management system is a regulatory requirement for marketing safe and effective devices. Each medical device manufacturer's quality management system needs will differ, and inputs for the system should be gathered from various sources. Project management and life cycle considerations need to be made internally to manage resources. No single solution satisfied all of the case company's preference pivoted towards highly configurable systems over rigid systems.