scholarly journals Critical Elements of the Medical Device Administration

2017 ◽  
Vol 2 (1) ◽  
pp. 1-5
Author(s):  
Naif B. Alsharari
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Field ◽  
Critical Elements ◽  
Administrative Program ◽  
Hardware Industry

The vast growth of medical devices in recent years in both innovation and its overall marketplace has profoundly impacted the medical field. This paper analyzes the critical elements of the medical device administrative program and researches the impacts of the influences of the demonstrative imaging hardware industry. The outcomes have indicated that the medical device direction has not impacted or influenced rivalry or development inside the various classes in this industry. This paper contains recommendations comprising of selected strategies for control that separate among levels of potential hazards to purchasers in which the objective of achieving buyer assurance can be accomplished with fewer undesirable consequences for the controlled business.

Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation

2021 ◽  
pp. 1-18
Author(s):  
Sofia Palmieri ◽  
Paulien Walraet ◽  
Tom Goffin
Keyword(s):  
Artificial Intelligence ◽  
European Commission ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Field ◽  
Medical Device Manufacturers ◽  
Regulatory Landscape ◽  
Medical Device Regulation ◽  
Regulatory Intervention

Abstract In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.

Interactive Computational Medical Device Deployments within Virtual Reality

2020 ◽  
Author(s):  
Alex J. Deakyne ◽  
Paul A. Iaizzo
Keyword(s):  
Virtual Reality ◽  
Medical Device ◽  
Medical Devices ◽  
3D Modeling ◽  
3D Models ◽  
Medical Field ◽  
Cardiac Device ◽  
Anatomical Features ◽  
Device Optimization ◽  
The Times

Abstract 3D modeling of anatomical features and medical devices are being used at increasing rates within the medical field. These 3D models allow for a wide variety of uses, such as educational or for medical device optimization. Next steps in such utilization are to perform computational and simulated device deployments within unique human anatomies. Such computational deployments have and will yield new perspectives and understandings relative to how given devices fit within the varied anatomies of varied patient populations. While these simulated device deployments offer many benefits, they are often time consuming to both develop and perform. Here, we present new functionalities to perform computational cardiac device deployments within virtual reality (VR). This functionality offers increased control of where the device is to be deployed, reducing the times required to perform computational device deployments in unique anatomical models.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

The Bioengineering Design Forum

1997 ◽  
Vol 11 (2) ◽  
pp. 116-119 ◽  
Author(s):  
Patrick J. Prendergast
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Device Industry ◽  
Industry Collaboration ◽  
University Industry ◽  
Device Industry

The author assesses the results of the Bioengineering Design Forum – a collaboration between university researchers, clinicians and industry in Ireland. The aim of the Forum is to initiate, develop and bring to a successful conclusion R&D collaborations that lead to new or improved medical devices. By laying down certain operating procedures for the Forum, an effective ‘meeting ground’ has been developed which serves the objectives of both university engineering departments and the medical device industry in a unique way. The purpose of this paper is to relate our experiences of the Forum; they may be useful to others who would like to attempt similar initiatives in other fields. The author also describes the results that may be expected from this kind of university–industry collaboration in practice.

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