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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
ISO 13485:2003/2016—Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
ISO 13485:2003 is published by various organizations, and when it is published by those organizations, this is recognized by letters being placed before the ISO 13485:2003. For example, in the Netherlands, it is published by Nederlands Normalisatie Institituut (NEN), and this is denoted by the Standard being NEN ISO 13485:2003, and as it is also a European Norm, it is published as NEN EN ISO 13485:2003.
A non-invasive direct nose to brain drug delivery platform vs. invasive brain delivery approach: patient-centered care impact analysis
Published in Drug Delivery, 2022
Ayala Kobo-Greenhut, Hilel Frankenthal, Aziz Darawsha, Avraham Karasik, Adit Zohar Beja, Tamir Ben Hur, Dana Ekstein, Lisa Amir, Daniel Shahaf, Izhar Ben Shlomo, Iris Shichor, William H. Frey
MTA evaluates medical technology based on medical efficacy as well as economic, socio-cultural, legal, ethical, and organizational factors (Parsons, 2021). The United States Food and Drug Administration (FDA) and European Commission’s notified bodies also evaluate medical technologies by focusing on technologies’ safe and effective performance. They rely on clinical trials and risk analyses, which are powerful tools for evidence based medical product safety and efficacy evaluation (Sherman et al., 2016; Grennan & Town, 2020). Additionally, both the FDA’s and European Commission’s notified bodies require that medical products undergo quality assessment via the International Organization for Standardization (ISO) 13485 certified quality management systems. The ISO 13485 specifies the requirements for medical device quality management systems for the purpose of regulatory and consumer oversight. However, regulatory oversight and quality assessment do not incorporate the patient-centered care perspective and thus do not guarantee the production of high-quality medical devices from this crucial perspective. In contrast, the principles of ‘quality’ in industry and marketing emphasize meeting the customer requirements and expectations, or in the case of healthcare systems, meeting the patient and/or patient’s family requirements and expectations. According to the Institute of Medicine (IOM), medical care should be ‘respectful of, and responsive to individual patient preferences, needs, and values, and ensures that patient values guide all clinical decisions’ (National Research Council, 2001).
Blood-based traumatic brain injury biomarkers – Clinical utilities and regulatory pathways in the United States, Europe and Canada
Published in Expert Review of Molecular Diagnostics, 2021
Kevin K. Wang, Jennifer C. Munoz Pareja, Stefania Mondello, Ramon Diaz-Arrastia, Cheryl Wellington, Kimbra Kenney, Ava M. Puccio, Jamie Hutchison, Nicole McKinnon, David O. Okonkwo, Zhihui Yang, Firas Kobeissy, J. Adrian Tyndall, András Büki, Endre Czeiter, Maria C. Pareja Zabala, Nithya Gandham, Rebecca Berman
In Europe, the regulatory framework for in vitro diagnostic medical devices is defined by the new European Union In Vitro Diagnostic Medical Device Regulation (IVDR) (2017/746), repealing the previous Directive 98/79/EC. IVD devices are considered a subset of medical devices primarily used for testing human fluids such as blood, tissue, or urine in a test tube. Depending on the IVD class – determined by the intended use and risk to the patient – the manufacturer provides a technical file that describes both analytical and clinical performance to support the proposed IVD indication/s and designates a European Authorized Representative (EAR) to act on its behalf with the regulatory bodies (Figure 4). More specifically, under IVDR, a TBI biomarker test is classified as a Class C device (the second-highest risk level), and the technical file, IVD safety aspects as well as the quality management system (QMS) of the manufacturer would be audited by both a European notified body and the European Medicines Agency (EMA)/National Competent Authorities (NCAs). Upon successful verification that the IVD mandatory requirements are met, a CE-Mark certification is issued by the notified body (Figure 4). Furthermore, in Europe, the ISO 13485 standard must be met. In addition, the obligation to register with the European Competent Authority where the authorized representative is located is also applied.
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.