Risk Management is the fundamental cornerstone on which global regulations are built. From device classification to post-market surveillance and obsolescence, the determination and on-going management of device risk is the underlying driver that guides manufacturer’s and economic operator’s product strategies, organisational structure and activities.
US FDA recognised the need for user-centred design as far back as the 1990’s, and published their guidance “Do it by Design, an Introduction to Human Factors in Medical Devices” in 1996. The importance of the device-user interaction has evolved over the intervening period, and the demonstration of device usability is now integral to medical device submissions globally.
The introduction of the usability engineering ISO standard in 2007, updated in 2015 and it's integration with the medical device risk management standard ISO 14971, marked the widespread acceptance of the need to fully consider the device user in the design; with the aim of identifying and mitigating ‘use errors’.
Our knowledge of and participation in the development of multiple horizontal and vertical international standards, that mitigate device risk, as well as the core risk management standard, ISO 14971, makes ARC Regulatory your ideal partner of choice for implementing compliance Risk Management and Usability Engineering in to your development life-cycle:
- We develop and implement integrated risk management strategies that are fully compliant with international requirements
- We ensure that the benefit of the device you bring to market truly outweighs the risks, protecting your business reputation in the event of post-market issues
- We train development teams on gold-standard application of risk management, and associated tools and techniques, ensuring accurate reflection of the risk of your medical device
ARC Regulatory has significant experience in working with development teams to ensure that the requirements of the device-user interface are fully understood; the primary operating functions and functions related to safety are identified, and studies are implemented at appropriate stages of device development, to understand how the user interacts and use error is mitigated as far as possible – all in the context of an over-arching risk management system in compliance with ISO 14971.