Software as a Medical Device: Need of the Hour (Preprint)

2020 ◽  
Author(s):  
Narmada S ◽  
◽  
Keyword(s):  
Health Outcomes ◽  
Medical Device ◽  
Medical Devices ◽  
Regulatory Agencies ◽  
Technological Innovations ◽  
Regulatory Requirements ◽  
The Road ◽  
Smartphone Use ◽  
Effective Use ◽  
Market Criteria

UNSTRUCTURED The rapid increase in smartphone use in the 21st century led to the introduction of many stand-alone health and medical devices. “Software intended to be used for one or more medical purposes without being part of a hardware medical device is referred as software as a medical device”. The design and regulatory science of SaMD depends on the early stages of software development that helps to assign them to different category of medical devices. Globally, there are tremendous technological innovations available that offered the opportunity to pursue a more efficient diagnosis and therapeutic solution compared to conventional approaches. The major benefits include tracking and altering the occurrence of a disease and improved health outcomes through rapid feedback, resulting in faster innovation. Apart from the advantages there are some technological challenges faced by SaMD such as maintaining the confidentiality, availability and integrity of patient data. The main objective is to provide the regulatory outline on the SaMD’s for safe and effective use by patients. The regulatory framework of both USFDA and EMA for software has been well structured when compared to other regulatory agencies. But more focus needs to be paid to pre-market criteria and the road to regulatory approval. The present study highlights the regulatory requirements for registering the SaMD in USA and European countries.

Stage-Gate Process for the Development of Medical Devices

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
Jan B. Pietzsch ◽  
Lauren A. Shluzas ◽  
M. Elisabeth Paté-Cornell ◽  
Paul G. Yock ◽  
John H. Linehan
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Business Processes ◽  
Development Model ◽  
Product Launch ◽  
Regulatory Requirements ◽  
Device Development ◽  
Study Results ◽  
Comprehensive Development ◽  
Device Industry

The medical device development process has become increasingly complex in recent years. The advent of new technology concepts, stricter regulatory requirements, and the ever increasing importance of reimbursement decisions for successful device commercialization require careful planning and strategy-setting, coordinated decisions, and consistent, rigorous business processes. The design and implementation of such processes, often captured in development models and accompanying standard operating procedures, have become a key determinant of the success of device commercialization. While various models may exist in the device industry, no comprehensive development model has been published. This paper reviews existing model representations and presents a new comprehensive development model that captures all aspects of device development and commercialization from early-concept selection to postmarket surveillance. This model was constructed based on best-practice analysis and in-depth interviews with more than 80 seasoned experts actively involved in the development, commercialization, and regulation of medical devices. The stage-gate process includes the following five phases: (1) initiation - opportunity and risk analysis, (2) formulation - concept and feasibility, (3) design and development - verification and validation, (4) final validation - product launch preparation, and (5) product launch and postlaunch assessment. The study results suggest that stage-gate processes are the predominant development model used in the medical device industry and that regulatory requirements such as the food and drug adminstration (FDA’s) Quality Systems Regulation play a substantive role in shaping activities and decisions in the process. The results also underline the significant differences between medical device innovation and drug discovery and development, and underscore current challenges associated with the successful development of the increasing number of combination products.

OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION

2013 ◽  
Vol 1 (1) ◽  
pp. 1-4
Author(s):  
Jitendra Kumar Badjatya
Keyword(s):  
Quality Of Life ◽  
Pharmaceutical Industry ◽  
Medical Devices ◽  
Legal Aspects ◽  
Pharmaceutical Products ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Pharmaceutical Drug ◽  
Regulatory Affairs

Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.

STUDY OF MOVEMENTS MOBILITY-IMPAIRED POPULATION GROUPS IN PEDESTRIAN ZONES OF THE STREET-ROAD NETWORK (in the example of city of Kiev)

2017 ◽  
Author(s):  
Oleksandra Cherednichenko ◽  
Keyword(s):  
European Union ◽  
Comparative Analysis ◽  
Road Network ◽  
Actual State ◽  
The European Union ◽  
Regulatory Requirements ◽  
Population Groups ◽  
The Road ◽  
Mobility Impaired

The results of the study of the main elements of unobstructed space are presented and the compliance of the actual state with the regulatory requirements of measures to ensure a safe, comfortable, accessible and informative pedestrian zone of the road network is analyzed. A comparative analysis of the main regulatory requirements for access ramps on the legislation of Ukraine and the European Union is carried out.

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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