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Quality and Safety Management
Published in W. P. M. Mayles, A. E. Nahum, J.-C. Rosenwald, Handbook of Radiotherapy Physics, 2021
W. P. M. Mayles, David Thwaites, J.-C. Rosenwald
Safety is defined by ISO as ‘the absence of unacceptable risk' (ISO 14971:2007). Since the total absence of risk is impossible, the aim of a safety management system is to minimise the risk of harmful events, this risk being a combination of the probability (or occurrence) and of the severity of an injury. Safety measures include actions to prevent incidents and arrangements put in place to mitigate their consequences if they were to occur. Although it requires specific approaches, safety management can be considered as an integral component of the quality system.
Regulatory Considerations When Deploying your Software in a Clinical Environment
Published in Johan Helmenkamp, Robert Bujila, Gavin Poludniowski, Diagnostic Radiology Physics with MATLAB®, 2020
Philip S. Cosgriff, Johan Åtting
Quality management: EN/ISO 13485:2016. Medical devices—quality management systems—requirements for regulatory purposesEN/ISO 14971:2012. Application of risk management to medical devicesISO 9001:2015. Quality management system—requirementsIEC/TR 80002-1:2009. Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device softwareIEC/TR 80002-2:2017. Medical device software—Part 2: Validation of software for medical device quality systems
European Union: Medical Device Regulatory System
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
The ISO 14971 sets for guidance related to risk management. The manufacturer shall establish, document and maintain throughout the life cycle an ongoing process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls. This process shall include the following elements:
A review on potential toxicity of dental material and screening their biocompatibility
Published in Toxicology Mechanisms and Methods, 2019
Shahriar Shahi, Mutlu Özcan, Solmaz Maleki Dizaj, Simin Sharifi, Nadin Al-Haj Husain, Aziz Eftekhari, Elham Ahmadian
Systematic approaches to estimate the bioavailability of newly produced materials are a part of toxicological evaluations in early stages of substance development. ISO standards due to their key role in meeting legal needs for premarketing biocompatibility assessments evaluate the toxicological profiles of materials/substances. Clinical risk assessments are carried out by means of ISO 14971 and ISO 10993-1. For instances, the instruction for the selection of the suitable techniques to test toxicity of medical devices which includes dental materials as well as the techniques themselves is presented in ISO 10993 series (Schmalz and Galler 2017). This standard encompasses 20 different parts at the moment. In addition to this standard, ISO 7405 is especially developed for devices used in dentistry (Schmalz and Fan 2009). European regulation on registration, evaluation, and authorization of chemicals (REACH) has several legislations to have a high level of protection of human health for consumers, workers, and the environment. Also, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health regulates the dental materials and devices marketed in the United States in three classes. However, due to the certain restrictions in determining material biocompatibility through preclinical examinations, post-marketing data should complete the picture through which dentist should report adverse effects.
The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review
Published in Disability and Rehabilitation, 2018
Ebrahim Sadeghi-Demneh, Saeed Forghany, Pornsuree Onmanee, Ursula Trinler, Michael P. Dillon, Richard Baker
As well as specific standards for devices, there is an increasing emphasis on quality management or quality assurance standards for manufacturing processes. In the year 2000, the International Society for Prosthetics and Orthotics (ISPO) held a workshop that produced detailed recommendations on Quality Management in Prosthetics and Orthotics [2]. While important at the time, most of these have been superseded in developed nations by more general national and international requirements for quality management across all industries. For example, the ISO 9000 family of standards were designed to ensure that manufactures meet statutory and regulatory requirements with ISO 9001 outlining the requirements they must fulfill. Prosthetic and orthotic devices are classified as medical devices which are covered by more specific standards. ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes is harmonized with ISO 9001 but without the requirements to demonstrate continual improvement or consider customer satisfaction. ISO 14971 Medical devices – Applications of risk management to medical devices establishes the detailed requirements for risk assessment required by ISO 13485.
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
ISO is an independent, nongovernmental, international organization with a membership of 162 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant international standards that support innovation and provide solutions to global challenges. It consists of 250 Technical Committees (TCs) and defines the scope of each TC [22]. In the medical device industry, for example, ISO/TC 210 ‘Quality management and corresponding general aspects for medical devices’ develops standards such as ISO 13485 ‘Medical devices – Quality management systems – Requirements for regulatory purposes’ and ISO 14971 ‘Medical devices – Application of risk management to medical devices.’ ISO/TC 194 ‘Biological and clinical evaluation of medical devices’ develops standards such as ISO 10993–1 ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’ and ISO 14155 ‘Clinical investigation of medical devices for human subjects – Good clinical practice.’ Further, ISO/TC 106 ‘Dentistry,’ ISO/TC 121 ‘Anesthetic and respiratory equipment,’ etc. develop many standards related to medical devices.