FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4226305299> ?p ?o ?g. }

• W4226305299 endingPage "91" @default.
• W4226305299 startingPage "71" @default.
• W4226305299 abstract "The regulatory area is one that restricts human behaviour and opportunities, but it also allows the prevention of loss of property, health, or even life in various fields. Regulations provide the market with public confidence, which is extremely important in the field of innovative medical devices. The aim of this article is to analyse critical factors and economic methods for regulatory impact assessment in the medical device industry, to focus on the finances, processes, or innovation activity of organisations operating in the medical device sector.The paper consists of a scoping review according to the PRISMA methodology of the available literature in Web of Science and Scopus database, whereby combing the keywords regulation AND innovation AND medical device AND economic impact, we obtained a set of 156 results in the form of English-written articles. The output was then limited to the period between 2011 and 2020. Finally, 23 papers were used based on the exclusion and inclusion criteria.The resulting challenges of the identified problems in particular are the amount of high-quality data available at an appropriate cost and the availability of a flexible notified body. There are also challenges specific to the situation, such as demands on the safety of medical devices for children. From a public expectations point of view, there is a continuing need to maintain the urgency of the balance between available innovation and safety.As for the methods of economic assessment in general, or methods for assessing the economic impact of regulations in particular, cost-effectiveness analysis is the most commonly used method for research and development, while internal rate of return is frequently used for the producers, and budget impact analysis is typically used for healthcare service providers. A non-financial indicator that is often discussed is the time demands associated with meeting compliance requirements. The time-to-market indicator is also often mentioned. Economic and financial topics are not discussed in depth, as the reviewed articles simply mention the generally high costs attendant on complying with regulations and obtaining certificates." @default.
• W4226305299 created "2022-05-05" @default.
• W4226305299 creator A5004052137 @default.
• W4226305299 creator A5083423743 @default.
• W4226305299 date "2022-01-01" @default.
• W4226305299 modified "2023-09-25" @default.
• W4226305299 title "Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry" @default.
• W4226305299 cites W1512694296 @default.
• W4226305299 cites W161660362 @default.
• W4226305299 cites W1967127897 @default.
• W4226305299 cites W1973612669 @default.
• W4226305299 cites W1974553989 @default.
• W4226305299 cites W1987443199 @default.
• W4226305299 cites W1996194859 @default.
• W4226305299 cites W2007054688 @default.
• W4226305299 cites W2008051579 @default.
• W4226305299 cites W2021409236 @default.
• W4226305299 cites W2024829323 @default.
• W4226305299 cites W2044703107 @default.
• W4226305299 cites W2068386500 @default.
• W4226305299 cites W2091728082 @default.
• W4226305299 cites W2106186877 @default.
• W4226305299 cites W2116247389 @default.
• W4226305299 cites W2129766124 @default.
• W4226305299 cites W2132253771 @default.
• W4226305299 cites W2157528491 @default.
• W4226305299 cites W2176645156 @default.
• W4226305299 cites W2290574262 @default.
• W4226305299 cites W2408813945 @default.
• W4226305299 cites W2462711463 @default.
• W4226305299 cites W2510469124 @default.
• W4226305299 cites W2512888127 @default.
• W4226305299 cites W2560232601 @default.
• W4226305299 cites W2593902008 @default.
• W4226305299 cites W2737361709 @default.
• W4226305299 cites W2750716829 @default.
• W4226305299 cites W2762267533 @default.
• W4226305299 cites W2790697527 @default.
• W4226305299 cites W2807331770 @default.
• W4226305299 cites W2885831669 @default.
• W4226305299 cites W2893814198 @default.
• W4226305299 cites W2903255087 @default.
• W4226305299 cites W2905485587 @default.
• W4226305299 cites W2940517996 @default.
• W4226305299 cites W2946758522 @default.
• W4226305299 cites W2982406877 @default.
• W4226305299 cites W2990882513 @default.
• W4226305299 cites W3005443559 @default.
• W4226305299 cites W3009233193 @default.
• W4226305299 cites W3010841383 @default.
• W4226305299 cites W3011198609 @default.
• W4226305299 cites W3011790489 @default.
• W4226305299 cites W3016375363 @default.
• W4226305299 cites W3016665598 @default.
• W4226305299 cites W3034855613 @default.
• W4226305299 cites W3040069742 @default.
• W4226305299 cites W3042047979 @default.
• W4226305299 cites W3042196102 @default.
• W4226305299 cites W3087725570 @default.
• W4226305299 cites W3089190864 @default.
• W4226305299 cites W3094530411 @default.
• W4226305299 cites W3107709629 @default.
• W4226305299 cites W3108725261 @default.
• W4226305299 cites W3114762159 @default.
• W4226305299 cites W3125886475 @default.
• W4226305299 cites W3159334517 @default.
• W4226305299 cites W4225939851 @default.
• W4226305299 cites W4240440582 @default.
• W4226305299 cites W4294215472 @default.
• W4226305299 cites W2922498032 @default.
• W4226305299 cites W3012753141 @default.
• W4226305299 doi "https://doi.org/10.2147/rmhp.s346928" @default.
• W4226305299 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/35082542" @default.
• W4226305299 hasPublicationYear "2022" @default.
• W4226305299 type Work @default.
• W4226305299 citedByCount "4" @default.
• W4226305299 countsByYear W42263052992022 @default.
• W4226305299 countsByYear W42263052992023 @default.
• W4226305299 crossrefType "journal-article" @default.
• W4226305299 hasAuthorship W4226305299A5004052137 @default.
• W4226305299 hasAuthorship W4226305299A5083423743 @default.
• W4226305299 hasBestOaLocation W42263052991 @default.
• W4226305299 hasConcept C111472728 @default.
• W4226305299 hasConcept C112930515 @default.
• W4226305299 hasConcept C136229726 @default.
• W4226305299 hasConcept C138885662 @default.
• W4226305299 hasConcept C144133560 @default.
• W4226305299 hasConcept C17744445 @default.
• W4226305299 hasConcept C199539241 @default.
• W4226305299 hasConcept C205649164 @default.
• W4226305299 hasConcept C2778952367 @default.
• W4226305299 hasConcept C2779473830 @default.
• W4226305299 hasConcept C2779530757 @default.
• W4226305299 hasConcept C3020535179 @default.
• W4226305299 hasConcept C58640448 @default.
• W4226305299 hasConcept C71924100 @default.
• W4226305299 hasConcept C83867959 @default.
• W4226305299 hasConceptScore W4226305299C111472728 @default.

• next