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Development of Medical Devices
Published in Waldemar Karwowski, Anna Szopa, Marcelo M. Soares, Handbook of Standards and Guidelines in Human Factors and Ergonomics, 2021
Omar Kheir, Alexis Jacoby, Stijn Verwulgen
ISO 14971 is a mandatory requirement for medical device manufacturers (Chan, Ip, & Zhang, 2012) where they should establish a system for risk management and a system for reporting incidents and field safety corrective actions. The FDA in the U.S. has published a guideline in 2006 for applying risk management in medical devices—“Guidance for Industry: Q9 Quality Risk Management.” Similar for the EU Regulation 2017/745 on “medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002, and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC” has been published in 2017 inspired by ISO 14971 with respect to risk management in medical devices.
Risk Analysis—Devices and Processes
Published in Paul H. King, Richard C. Fries, Arthur T. Johnson, Design of Biomedical Devices and Systems, 2018
Paul H. King, Richard C. Fries, Arthur T. Johnson
ISO 14971 is an ISO standard for the application of risk management to medical devices. The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group 1. This standard is the culmination of the work starting in ISO/IEC Guide 51 and ISO/IEC Guide 63. The latest significant revision was published in 2007 with a minor update published in 2009. In 2013, a technical report ISO/TR 24971 was published by ISO TC 210 to provide expert guidance on the application of this standard.
Foundational Analyses
Published in Chris Hobbs, Embedded Software Development for Safety-Critical Systems, 2017
The idea of this analysis is to identify risks associated with the component or device, to determine mitigations to reduce those risks, preferably to zero, and then to determine what residual risks are left. ISO 14971, even though written for medical devices, provides a set of useful guidelines for identifying and mitigating hazards and risks and could be used to advantage even on projects not related to medical devices.
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives
Published in Expert Review of Medical Devices, 2023
Alan G Fraser, Elisabetta Biasin, Bart Bijnens, Nico Bruining, Enrico G Caiani, Koen Cobbaert, Rhodri H Davies, Stephen H Gilbert, Leo Hovestadt, Erik Kamenjasevic, Zuzanna Kwade, Gearóid McGauran, Gearóid O’Connor, Baptiste Vasey, Frank E Rademakers
For general guidance relating to medical devices, the EU regulatory system applies ISO 13485 about quality management systems [93], ISO standard 14,155 which describes the clinical investigation of medical devices [94] (or more correctly their equivalents EN ISO 13485:2016, and EN ISO 14155:2020, but note that only the first of these has been harmonized to the MDR), and ISO 14971 on risk management [95]. ISO 14155 recommends principles for clinical evaluation and mentions types of studies (in Annex I) but it does not prescribe particular methodologies or clinical trials whether for AI systems or any other type of medical device. A new and more specific ISO standard concerning clinical evaluation for medical devices has been proposed, to recommend methodologies for collecting and appraising clinical data across the full lifecycle of a device. If formally adopted, then responsibility for developing and producing the standard within 3 years will be passed to the same working group that prepared ISO 14155 (namely ISO/TC 194 WG4).
Usability engineering in practice: developing an intervention for post-stroke therapy during a global pandemic
Published in Journal of Medical Engineering & Technology, 2022
Avril D. McCarthy, Louise Moody, Mark L. Reeves, T. Jamie Healey, Tim Good, Lise Sproson, Adewale Adebajo, Wendy Tindale, Krishnan Padmakumari Sivaraman Nair
Table 1 outlines some of the UK, European and International standards and recommendations relating to medical devices, risk management, electrical safety and human factors engineering – areas that are commonly intertwined in ensuring safe and acceptable device usability. Within Table 1 the ISO 14971 standard [8] relates to risk management and this should be applied during the life cycle of all forms of medical device. Depending on whether the device is electrically powered and/or employs software, will also influence the selection and use of other specific standards highlighted in Table 1 such as the IEC 60601 family for medical electrical equipment or IEC 62304 [11] for medical device software. IEC 62366 [10] relates specifically to medical device usability during normal usage. However, IEC 60601-1-6 [12], which also focuses on usability, may be more appropriate to employ when developing electrical medical devices. The context of usage is also important, and within the 60601 family is 60601-1-11 [13], which focuses on intended medical device use in the home environment. Again referenced in Table 1, the UK’s medical device regulator (the MHRA), the European Commission and the American National Standards Institute (ANSI) have provided guidance, recommendations and updated medical device regulations centring on usability engineering and human factors. Thus reflecting the importance of achieving effective usability to reduce user risk and deliver safe devices able to meet regulatory compliance requirements.