Device Registration Research Articles

IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices Introduction and Consideration

IMDRF revised the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (hereinafter referred to as "EP"), which further promoted the unification of medical device safety and effectiveness internationally. In order to strengthen the scientific review of medical device and deepen the understanding of EP, we introduce EP, focus on the role of EP and the connection with the construction of quality management systems, risk and benefit determination, and registration, analyze the problems and reasons in the process of medical device registration, and give suggestions to promote the application of EP.

Quick and efficient network access schemes for IoT devices

In an IoT (Internet of Things) network, nodes need first to access the network resources before they can transmit data. If the data to be transmitted require real-time guarantees, then the node should not be stuck in the process of accessing resources. Quick and efficient access to the network resources is desirable for timely data communication. To this end, we have studied the IEEE 802.15.4 and IEEE 802.15.4e-TSCH standards and have proposed energy-efficient algorithms to ensure that the nodes can access the resources at the earliest. We have proposed a “Device Registration” algorithm for IEEE 802.15.4 networks, which aims at increasing accessibility of the Guaranteed Time Slots (GTSs) available in the superframe. The algorithm can be implemented by making minor modifications to the parameters within the existing MAC framework. Similarly, we have proposed a “Sparse Beacon Advertisement”, a beacon scheduling algorithm, for IEEE 802.15.4e-TSCH networks that aims at reducing the wait time for a new node before it joins the network, even when there are few beacons being advertised. Both these algorithms have been evaluated extensively using simulations and experiments on a testbed. Our results show that in an IEEE 802.15.4 network, with the proposed algorithm, nodes are twice as successful in accessing the GTS resources as they were before. Similarly, Sparse Beacon Advertisement reduces the joining times by at least 60% in an IEEE 802.15.4e-TSCH network.

A Secure Cloud-centric IoT Framework for Smart Device Registration

A Secure Cloud-centric IoT Framework for Smart Device Registration

Evolution of Medical Device Sector in India and Comparison of Registration Processes of Medical Devices in India with Countries like China, Australia, U.S. and Europe

The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments Make in India Campaign 2017, and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). In China, the registration approval process is under NMPA (National Medical Product Administration) and requires complying with Chinese regulatory standard notice No. 218. Europe and Australian regulations are bit same and require a CE (Conformité Européenne) mark for manufacturing and marketing. U.S. regulations for approving medical devices are stringent and 510 (k) and PMA (pre-market authorization) is compulsory. In this review, the reader would get an idea about the evolution of medical devices and legislative changes in India and also about international standards and auditing programs. There is a comparison of Indian, Chinese, Australian, U.S., and European medical device registration processes for understanding the similarities and differences.

FogAuthChain: A secure location-based authentication scheme in fog computing environments using Blockchain

Fog computing is an emerging computing paradigm which expands cloud-based computing services near the network edge. With this new computing paradigm, new challenges arise in terms of security and privacy. These concerns are due to the distributed ownership of Fog devices. Because of the large scale distributed nature of devices at the Fog layer, secure authentication for communication among these devices is a major challenge. The traditional authentication methods (password-based, certificate-based and biometric-based) are not directly applicable due to the unique architecture and characteristics of the Fog. Moreover, the traditional authentication methods consume significantly more computation power and incur high latency, and this does not meet the key requirements of the Fog. To fill this gap, this article proposes a secure decentralised location-based device to device (D2D) authentication model in which Fog devices can mutually authenticate each other at the Fog layer by using Blockchain. We considered an Ethereum Blockchain platform for the Fog device registration, authentication, attestation and data storage. We presented the overall system architecture, various participants and their transactions and message interaction between the participants. We validated the proposed model by comparing it with the existing method; results showed that the proposed authentication mechanism was efficient and secure. From the performance evaluation, it was found that the proposed method is computationally efficient and secure in a highly distributed Fog network.

All-Passive Hardware Implementation of Multilayer Perceptron Classifiers.

Bottom-up-fabricated crossbars promise superior circuit density and 3-D integrability compared with the traditional CMOS-based implementations. However, their inherent stochasticity presents difficulties in building complex circuits from components that demand precise patterning and high registration accuracies. With fewer terminals than active devices, passive components offer higher device densities and registration tolerances, making them amenable to bottom-up synthesized nanocrossbars. Motivated by this preference for passivity, we explore, in this article, neuromorphic classifiers based on passive neurons and passive synapses. We demonstrate via SPICE simulations how a shallow network of the diode-resistor-based passive rectifier neurons and resistive voltage summers, despite its inherent inability to buffer, amplify, and negate signals, can recognize MNIST digits with 95.4% accuracy. We introduce weight-to-conductance mappings that enable negative weights to be implemented in hardware without excessive memory overheads. The influences of soft and hard defects on the classification performance are evaluated, and the methods to boost fault-tolerance are proposed. The first-order evaluation of the area, speed, and power consumption of the passive multilayer perceptron classifiers is undertaken, and the results are compared with a benchmark study in neuromorphic hardware.

Wie weit ist Chirugie 4.0?

The increasing networking of data systems in medicine is not only leading to modern interdisciplinarity in the sense of cooperation between different medical departments, but also poses new challenges regarding the building and room infrastructure. The surgical operating room of the future expands or augments its reality, away from the pure building characteristics, towards an intelligent and communicative space platform. The building infrastructure (operating theatre) serves as sensor and actuator. Thus, it is possible to inform about missing diagnostics as well as to register them directly in the contextualization of the planned surgical intervention or to integrate them into the processes. Integrated operating theatres represent acomprehensive computer platform based on acorresponding system architecture with software-based protocols. An underlying modular system consisting of various modules for image acquisition and analysis, interaction and visualization supports the integration and merging of heterogeneous data that are generated in ahospital operation. Integral building data (e.g., air conditioning, lighting control, device registration) are merged with patient-related data (age, type of illness, concomitant diseases, existing diagnostic CT and MRI images). New systems coming onto the market, as well as already existing systems will have to be measured by the extent to which they will be able to guarantee this integration of information-similar to the development from mobile phone to smartphone. Cost reduction should not be the only legitimizing argument for the market launch, but the vision of anew quality of surgical perception and action.

Three Dimensional Visualisation of Endovascular Guidewires and Catheters Based on Laser Light instead of Fluoroscopy with Fiber Optic RealShape Technology: Preclinical Results

Fiber Optic RealShape (FORS) is a new technology platform that enables real time three dimensional (3D) visualisation of endovascular guidewires and catheters, based on the concepts of fibre optic technology instead of fluoroscopy. Anatomical context is provided by means of co-registered prior anatomical imaging, such as digital subtraction angiography or computed tomography. This preclinical study assesses the safety and feasibility of FORS technology. Six physicians performed endovascular tasks in a phantom model and a porcine model using FORS enabled floppy guidewires, Cobra-2 catheters and Berenstein catheters. Each physician performed a set of predefined tasks in both models, including setup of the FORS system, device registration, and 12 aortic and peripheral target vessel cannulation tasks. The evaluation of the FORS system was based on (i) target vessel cannulation success; (ii) safety assessment; (iii) the accuracy of the FORS based device visualisation; and (iv) user experience. Successful cannulation was achieved in 72 of the 72 tasks (100%) in the phantom model and in 70 of the 72 tasks (97%) in the porcine model. No safety issues were reported. The FORS based device visualisation had a median offset at the tip of 2.2mm (interquartile range 1.2-3.8mm). The users judged the FORS based device visualisation to be superior to conventional fluoroscopic imaging, while not affecting the mechanical properties (torquability, pushability) of the FORS enabled guidewire and catheters. The combined outcomes of high cannulation success, positive user experience, adequate accuracy, and absence of safety issues demonstrate the safety and feasibility of the FORS system in a preclinical environment. FORS technology has great potential to improve device visualisation in endovascular interventions.

Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process

In order to strengthen the supervision and management of medical devices, China implements pre-market registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.

Application of International Medical Device Electronic Registration

The eRPS system for medical device registration of National Medical Products Administration was officially launched on June 24, 2019. This paper focused on the following two aspects of the electronic declaration process of medical device regulatory agencies in the whole world:one is whether the electronic submission format is consistent, the other is whether the electronic submission path is convenient. Suggestions are put forward for the next nationwide implementation of the electronic submission so as to speed up the process of the electronization of medical device evaluation in China.

Design Elements of Medical Endoscope and Concerns of Registration Technical Evaluation

From the point of view of medical device registration technical evaluation, production process of endoscope, three-dimensional imaging(3D), high resolution imaging are discussed. We focus on the process of design and development, especially verification and validation. The general principle is that all risks and unexpected impacts should be minimized and acceptable to ensure that benefits are greater than risks in normal use.

LEO IoT based big data management and analysis platform design for intermodal containers

In view of the global information management requirements of intermodal containers, combined with the development status, this paper proposes an IoT model based on LEO satellites, and a big data management and analysis platform based on the model. This paper designs and analyses the scheme of the platform, and proposes a middleware approach to solve the problem of multi-source heterogeneous data access of containers intelligent terminals. Then, this paper designs business processes such as user and device registration, middleware registration, historical data access, and timely data access for the platform. The big data analysis and management platform has been prototyped and verified; the platform has the advantages of compatibility, openness and convenience. This study has certain value.

Study on Feasibility and Countermeasures of Social Third-party EMC Testing for Medical Device Registration

In view of the background that the regulation of medical device supervision and management is about to cancel the registration and inspection, this paper analyses the risk of electromagnetic compatibility of medical devices, combs the current situation of electromagnetic compatibility testing, discusses the factors to be considered in the approval of third-party testing reports, and gives relevant solutions suitable for China's national conditions.

Development of a device for registration and processing of EMG signals for a prototype of a bionic prosthetic hand

This paper presents the stages of development of the device registration and processing of the EMG signal, the structural and schematic diagram of the device and the PCB of the device. The experimental results of testing the device in the form of oscillograms of EMG signals and control pulse signals that control the operation of the prototype bionic prosthetic hand are also presented.

IOT STATUS COMMUNICATION FOR HOME AUTOMATION

The vast majority of home automation systems depend on a permanent central controller and this is the source of many serious problems. The controller may be eliminated by using one or more Intermittent Control Devices such as a smartphone, but the responsibilities of the controller must be redistributed. This paper considers the problem of keeping multiple intermittent controllers up-to-date with status information for devices around the home. Four protocols are proposed, taking key lessons from existing network protocols, and then implemented, tested and compared with the expected performance of UPnP. All four protocols outperform UPnP and further analysis shows that these protocols can be implemented in a robust and user-friendly manner. A comparison of the packet efficiency of these protocols demonstrates that the combination of device registration and packet broadcasting makes for the most efficient protocol and should form the basis of devices status communications in home automation systems without a permanent central controller.

Discussion on the Sterilization Material in the Registration Evaluation of Sterile Medical Device

This article first introduces the regulation requirements for sterilization material in the registration evaluation of sterile medical devices. Secondly, the article chooses the suture passer set kit with multiple sterilization methods as an example product for technical evaluation. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluators how to make the evaluation for the medical device registration.

Discussion on Technical Evaluation of Magnetocardiography

There is no corresponding product standard and industry standard for the search and development of magnetocardiograph at home and abroad. In this paper, based on the working principle and clinical application function of magnetocardiograph, and on the basis of relevant regulations and normative documents of medical device registration, some thoughts and concerns about the technical review of this kind of product are put forward.

CKMI: Comprehensive Key Management Infrastructure Design for Industrial Automation and Control Systems

Industrial Automation and Control Systems (IACS) are broadly utilized in critical infrastructures for monitoring and controlling the industrial processes remotely. The real-time transmissions in such systems provoke security breaches. Many security breaches have been reported impacting society severely. Hence, it is essential to achieve secure communication between the devices for creating a secure environment. For this to be effective, the keys used for secure communication must be protected against unauthorized disclosure, misuse, alteration or loss, which can be taken care of by a Key Management Infrastructure. In this paper, by considering the generic industrial automation network, a comprehensive key management infrastructure (CKMI) is designed for IACS. To design such an infrastructure, the proposed scheme employs ECDH, matrix method, and polynomial crypto mechanisms. The proposed design handles all the standard key management operations, viz. key generation, device registration, key establishment, key storage, device addition, key revocation, key update, key recovery, key archival, and key de-registration and destruction. The design supports secure communication between the same and different levels of IACS devices. The proposed design can be applied for major industrial automation networks to handle the key management operations. The performance analysis and implementation results highlight the benefits of the proposed design.

Reference and Innovation: Research on the Construction of Medical Device Registrar System

In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.

Study on Regulations of Exemption in Medical Device Registration and Approval Process in the United States and China

Registration and approval is a necessary step in product marketing process of new medical devices to ensure their safety and efficiency.At present,many countries are relatively strict in the management of high risk medical devices,especially for class Ⅲ medical devices.Taking clinical trials as examples,they cost too many human,material resources.FDA has introduced a variety of regulations and policies to streamline the registration process to speed up the product marketing process.Based on the introduction of the relevant regulations on the exemption in parts of medical device registration and approval process in the United States,this paper compares and analyzes the simplified status of medical device approval in China.In the end,the significance of exemption in the registration and approval process is expounded,and some suggestions on how to optimize and approve the registration and approval process of medical devices in China are put forward.