A Rule-Based Model for Compliance of Medical Devices Applied to the European Market

2019 ◽  
Vol 1 (2) ◽  
pp. 56-78 ◽  
Author(s):  
Sofia Almpani ◽  
Petros Stefaneas ◽  
Harold Boley ◽  
Theodoros Mitsikas ◽  
Panayiotis Frangos
Keyword(s):  
Knowledge Base ◽  
Open Source ◽  
Medical Devices ◽  
Feedback Loop ◽  
European Market ◽  
Conformity Assessment ◽  
Rule Based ◽  
Consumer Interest ◽  
Regulatory Frameworks

There is a growing producer and consumer interest in medical devices and the commensurate need for regulatory frameworks to ensure the quality of medical devices marketed locally and globally. This work focuses on formalizing the clauses enacted by Regulation (EU) 2017/745 for risk-based classification and class-based conformity assessment regarding marketability of medical devices. The resulting knowledge base (KB) represents clauses in Positional-Slotted Object-Applicative (PSOA) RuleML by integrating F-logic-like frames with Prolog-like relationships for atoms used as facts and in the conclusions and conditions of rules. Rules can apply polyadic functions, define polyadic relations, and augment conclusions with actions and conditions with events. The PSOA RuleML-implemented Medical Devices Rules KB was tested by querying in the open-source Java-implemented PSOATransRun system, which has provided a feedback loop for refinement and extension. This prototype can contribute to the licensing process of stakeholders and the registration of medical devices with a CE conformity mark.

scholarly journals ExosCE: A legal-based computational system for compliance with exoskeletons’ CE marking

2020 ◽  
Vol 11 (1) ◽  
pp. 414-427
Author(s):  
Sofia Almpani ◽  
Theodoros Mitsikas ◽  
Petros Stefaneas ◽  
Panayiotis Frangos
Keyword(s):  
Open Source ◽  
Medical Devices ◽  
Real Life ◽  
Conformity Assessment ◽  
Medical Applications ◽  
Computational System ◽  
Python Script ◽  
Wearable Robots ◽  
Assessment Procedures

AbstractWearable robots are devices intended to improve the quality of users’ life by augmenting, assisting, or substituting human functions. Exoskeletons are one of the most widespread types of wearable robots, currently used extensively in medical applications (and also for industrial, assistive, or military purposes), thus governed by regulations for medical devices and their conformity assessment. On top of that, manufacturers must also specify if their exoskeletons can be categorized as machines and, therefore, additionally apply a number of requirements mandated from machinery regulations. This work focuses on capturing both the abovementioned requirements enacted by the Medical Devices Directive 2017/745 and the Machinery Directive 2006/42 into a single framework. It formalizes into Rules the Conformity Assessment procedures regarding the marketability of exoskeletons indicated by the CE marking (“Conformité Européene”). These Rules, expressed in the Positional-Slotted Object-Applicative (PSOA) RuleML code, were complemented by representative Facts based on real-life cases of commercialized exoskeletons. Additional Exoskeletons Facts can be included by users from other forms (such as MS Excel) and translated into the PSOA RuleML code through the provided Python script. The open-source Exoskeletons’ CE mark (ExosCE) Rules KB was tested by querying in the open-source PSOATransRun system. The ExosCE Rules prototype can assist in the compliance process of stakeholders and in the registration of exoskeletons with a CE mark.

scholarly journals Sistem Evaluasi Jamunan Mutu Menggunakan Rule Based System Untuk Monitoring Mutu Perguruan Tinggi

2017 ◽  
Vol 7 (1) ◽  
pp. 24
Author(s):  
Sri Hartono
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Knowledge Base ◽  
Recommendation System ◽  
Study Program ◽  
Rule Based ◽  
Rule Based System ◽  
Quality Of Higher Education ◽  
Quality Status

The needs for continuous quality improvement resulting in the more complex. The research aims to develop system of quality assurance evaluation using rule based system to monitor the quality of higher education. This process of the research begins by documenting the daily activity of study program which consists of lecturer data, research data, service data, staff data, student data, and infrastructure data into a database. The data were evaluated by using rule based system  by adopting rules on quality standards of study program of National Accreditation Board for Higher Education as the knowledge base. Evaluation process was carried out by using the forward chaining methods by matching the existing data to the knowledge base to determine the quality status of each quality standard. While the reccomendation process was carried out by using the backward chaining methods by matching the results of quality status to the desired projection of quality status to determine the nearest target which can be achieved. The result of the research is system of quality assurance evaluation with rule based system that is capable of producing an output system in the form of internal evaluation report and recommendation system that can be used to monitor the quality of higher education. 

Biological Evaluation of Medical Devices: A Review of EU Regulations, with Emphasis on In Vitro Screening for Biocompatibility

1995 ◽  
Vol 23 (4) ◽  
pp. 469-473
Author(s):  
Gottfried Schmalz
Keyword(s):  
Medical Devices ◽  
Quality Standards ◽  
Biological Evaluation ◽  
Conformity Assessment ◽  
European Economic Area ◽  
In Vitro Screening ◽  
European Economic ◽  
Economic Area

— The quality of medical devices (including their biocompatibility) is regulated throughout the European Economic Area by Directive 93/42/EEC, which came into effect on 1 January 1995. The CE (conformity assessment) mark placed on the device shows conformity with the essential requirements, which guarantee the desired level of quality. Standards can be used to prove this conformity with the essential requirements. Scientific input is needed to produce and update relevant standards.

DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

2015 ◽  
Vol 3 (2) ◽  
pp. 1-7 ◽  
Author(s):  
Achin Jain ◽  
M P Venkatesh M P ◽  
Pramod T.M. Kumar
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Emerging Market ◽  
Well Being ◽  
New Drugs ◽  
Regulatory Body ◽  
Herbal Drugs ◽  
Drug Products ◽  
Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 

A Human/Computer Learning Network to Improve Biodiversity Conservation and Research

AI Magazine ◽  
2012 ◽  
Vol 34 (1) ◽  
pp. 10 ◽  
Author(s):  
Steve Kelling ◽  
Jeff Gerbracht ◽  
Daniel Fink ◽  
Carl Lagoze ◽  
Weng-Keen Wong ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Feedback Loop ◽  
Human Computation ◽  
Computational Power ◽  
Learning Networks ◽  
Learning Network ◽  
Computer Learning ◽  
The Individual ◽  
Citizen Science Project

In this paper we describe eBird, a citizen-science project that takes advantage of the human observational capacity to identify birds to species, which is then used to accurately represent patterns of bird occurrences across broad spatial and temporal extents. eBird employs artificial intelligence techniques such as machine learning to improve data quality by taking advantage of the synergies between human computation and mechanical computation. We call this a Human-Computer Learning Network, whose core is an active learning feedback loop between humans and machines that dramatically improves the quality of both, and thereby continually improves the effectiveness of the network as a whole. In this paper we explore how Human-Computer Learning Networks can leverage the contributions of a broad recruitment of human observers and processes their contributed data with Artificial Intelligence algorithms leading to a computational power that far exceeds the sum of the individual parts.

scholarly journals A standardized framework for testing the performance of sleep-tracking technology: step-by-step guidelines and open-source code

SLEEP ◽  
2020 ◽  
Author(s):  
Luca Menghini ◽  
Nicola Cellini ◽  
Aimee Goldstone ◽  
Fiona C Baker ◽  
Massimiliano de Zambotti
Keyword(s):  
Open Source ◽  
Validation Studies ◽  
Large Scale ◽  
Analytical Framework ◽  
Clinical Settings ◽  
Large Scale Data ◽  
Fast Pace ◽  
Epoch Analysis ◽  
Tracking Devices

Abstract Sleep-tracking devices, particularly within the consumer sleep technology (CST) space, are increasingly used in both research and clinical settings, providing new opportunities for large-scale data collection in highly ecological conditions. Due to the fast pace of the CST industry combined with the lack of a standardized framework to evaluate the performance of sleep trackers, their accuracy and reliability in measuring sleep remains largely unknown. Here, we provide a step-by-step analytical framework for evaluating the performance of sleep trackers (including standard actigraphy), as compared with gold-standard polysomnography (PSG) or other reference methods. The analytical guidelines are based on recent recommendations for evaluating and using CST from our group and others (de Zambotti and colleagues; Depner and colleagues), and include raw data organization as well as critical analytical procedures, including discrepancy analysis, Bland–Altman plots, and epoch-by-epoch analysis. Analytical steps are accompanied by open-source R functions (depicted at https://sri-human-sleep.github.io/sleep-trackers-performance/AnalyticalPipeline_v1.0.0.html). In addition, an empirical sample dataset is used to describe and discuss the main outcomes of the proposed pipeline. The guidelines and the accompanying functions are aimed at standardizing the testing of CSTs performance, to not only increase the replicability of validation studies, but also to provide ready-to-use tools to researchers and clinicians. All in all, this work can help to increase the efficiency, interpretation, and quality of validation studies, and to improve the informed adoption of CST in research and clinical settings.

scholarly journals Benefits of Conformity Assessment for Cybersecurity Standards of Diabetes Devices and Other Medical Devices

2021 ◽  
pp. 193229682110181
Author(s):  
Trisha Shang ◽  
Jennifer Y. Zhang ◽  
Joe Dawson ◽  
David C. Klonoff
Keyword(s):  
Medical Devices ◽  
Conformity Assessment

scholarly journals Internal Quality Evolution of Open-Source Software Systems

2021 ◽  
Vol 11 (12) ◽  
pp. 5690
Author(s):  
Mamdouh Alenezi
Keyword(s):  
Open Source ◽  
Open Source Software ◽  
Software Evolution ◽  
Quality Metrics ◽  
Internal Quality ◽  
Software Systems ◽  
Software Metric ◽  
Significant Difference ◽  
The Relationship

The evolution of software is necessary for the success of software systems. Studying the evolution of software and understanding it is a vocal topic of study in software engineering. One of the primary concepts of software evolution is that the internal quality of a software system declines when it evolves. In this paper, the method of evolution of the internal quality of object-oriented open-source software systems has been examined by applying a software metric approach. More specifically, we analyze how software systems evolve over versions regarding size and the relationship between size and different internal quality metrics. The results and observations of this research include: (i) there is a significant difference between different systems concerning the LOC variable (ii) there is a significant correlation between all pairwise comparisons of internal quality metrics, and (iii) the effect of complexity and inheritance on the LOC was positive and significant, while the effect of Coupling and Cohesion was not significant.

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