FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4319293896> ?p ?o ?g. }

• W4319293896 endingPage "2159" @default.
• W4319293896 startingPage "2144" @default.
• W4319293896 abstract "Introduction The recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a higher risk category, thus requiring more data before market approval, and a much larger focus has been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity. However, the requirements of clinical study design and developmental outcomes are only described in general terms due to the diversity of devices. Methods A structured approach to determining the requirements for the clinical development of high‐risk medical devices is introduced, utilizing the question‐based development framework, which is already used for pharmaceutical drug development. An example of a novel implantable device for haemodialysis demonstrates how to set up a relevant target product profile defining the device requirements and criteria. The framework can be used in the medical device design phase to define specific questions to be answered during the ensuing clinical development, based upon five general questions, specified by the question‐based framework. Results The result is a clear and evaluable overview of requirements and methodologies to verify and track these requirements in the clinical development phase. Development organizations will be guided to the optimal route, also to abandon projects destined for failure early on to minimize development risks. Conclusion The framework could facilitate communication with funding agencies, regulators and clinicians, while highlighting remaining ‘known unknowns’ that require answering in the post‐market phase after sufficient benefit is established relative to the risks." @default.
• W4319293896 created "2023-02-07" @default.
• W4319293896 creator A5004991538 @default.
• W4319293896 creator A5021119878 @default.
• W4319293896 creator A5047227576 @default.
• W4319293896 creator A5052997406 @default.
• W4319293896 creator A5053899866 @default.
• W4319293896 creator A5087801897 @default.
• W4319293896 date "2023-02-16" @default.
• W4319293896 modified "2023-09-27" @default.
• W4319293896 title "Question‐based development of high‐risk medical devices: A proposal for a structured design and review process" @default.
• W4319293896 cites W2022444659 @default.
• W4319293896 cites W2028182286 @default.
• W4319293896 cites W2032872781 @default.
• W4319293896 cites W206249643 @default.
• W4319293896 cites W2088174570 @default.
• W4319293896 cites W2091367091 @default.
• W4319293896 cites W2136174240 @default.
• W4319293896 cites W2195724327 @default.
• W4319293896 cites W2588719504 @default.
• W4319293896 cites W2790697527 @default.
• W4319293896 cites W2984437011 @default.
• W4319293896 cites W3087328191 @default.
• W4319293896 cites W3099394734 @default.
• W4319293896 cites W3188274719 @default.
• W4319293896 cites W4205475777 @default.
• W4319293896 cites W4226305059 @default.
• W4319293896 cites W4233217708 @default.
• W4319293896 doi "https://doi.org/10.1111/bcp.15685" @default.
• W4319293896 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/36740771" @default.
• W4319293896 hasPublicationYear "2023" @default.
• W4319293896 type Work @default.
• W4319293896 citedByCount "1" @default.
• W4319293896 countsByYear W43192938962023 @default.
• W4319293896 crossrefType "journal-article" @default.
• W4319293896 hasAuthorship W4319293896A5004991538 @default.
• W4319293896 hasAuthorship W4319293896A5021119878 @default.
• W4319293896 hasAuthorship W4319293896A5047227576 @default.
• W4319293896 hasAuthorship W4319293896A5052997406 @default.
• W4319293896 hasAuthorship W4319293896A5053899866 @default.
• W4319293896 hasAuthorship W4319293896A5087801897 @default.
• W4319293896 hasBestOaLocation W43192938961 @default.
• W4319293896 hasConcept C111919701 @default.
• W4319293896 hasConcept C112930515 @default.
• W4319293896 hasConcept C118552586 @default.
• W4319293896 hasConcept C127413603 @default.
• W4319293896 hasConcept C136229726 @default.
• W4319293896 hasConcept C144133560 @default.
• W4319293896 hasConcept C154945302 @default.
• W4319293896 hasConcept C160735492 @default.
• W4319293896 hasConcept C162324750 @default.
• W4319293896 hasConcept C162853370 @default.
• W4319293896 hasConcept C177264268 @default.
• W4319293896 hasConcept C17744445 @default.
• W4319293896 hasConcept C19351080 @default.
• W4319293896 hasConcept C195094911 @default.
• W4319293896 hasConcept C199360897 @default.
• W4319293896 hasConcept C199539241 @default.
• W4319293896 hasConcept C2777212361 @default.
• W4319293896 hasConcept C2777351106 @default.
• W4319293896 hasConcept C2779328685 @default.
• W4319293896 hasConcept C2780035454 @default.
• W4319293896 hasConcept C3020535179 @default.
• W4319293896 hasConcept C41008148 @default.
• W4319293896 hasConcept C50522688 @default.
• W4319293896 hasConcept C64903051 @default.
• W4319293896 hasConcept C71924100 @default.
• W4319293896 hasConcept C98045186 @default.
• W4319293896 hasConceptScore W4319293896C111919701 @default.
• W4319293896 hasConceptScore W4319293896C112930515 @default.
• W4319293896 hasConceptScore W4319293896C118552586 @default.
• W4319293896 hasConceptScore W4319293896C127413603 @default.
• W4319293896 hasConceptScore W4319293896C136229726 @default.
• W4319293896 hasConceptScore W4319293896C144133560 @default.
• W4319293896 hasConceptScore W4319293896C154945302 @default.
• W4319293896 hasConceptScore W4319293896C160735492 @default.
• W4319293896 hasConceptScore W4319293896C162324750 @default.
• W4319293896 hasConceptScore W4319293896C162853370 @default.
• W4319293896 hasConceptScore W4319293896C177264268 @default.
• W4319293896 hasConceptScore W4319293896C17744445 @default.
• W4319293896 hasConceptScore W4319293896C19351080 @default.
• W4319293896 hasConceptScore W4319293896C195094911 @default.
• W4319293896 hasConceptScore W4319293896C199360897 @default.
• W4319293896 hasConceptScore W4319293896C199539241 @default.
• W4319293896 hasConceptScore W4319293896C2777212361 @default.
• W4319293896 hasConceptScore W4319293896C2777351106 @default.
• W4319293896 hasConceptScore W4319293896C2779328685 @default.
• W4319293896 hasConceptScore W4319293896C2780035454 @default.
• W4319293896 hasConceptScore W4319293896C3020535179 @default.
• W4319293896 hasConceptScore W4319293896C41008148 @default.
• W4319293896 hasConceptScore W4319293896C50522688 @default.
• W4319293896 hasConceptScore W4319293896C64903051 @default.
• W4319293896 hasConceptScore W4319293896C71924100 @default.
• W4319293896 hasConceptScore W4319293896C98045186 @default.
• W4319293896 hasIssue "7" @default.
• W4319293896 hasLocation W43192938961 @default.
• W4319293896 hasLocation W43192938962 @default.
• W4319293896 hasLocation W43192938963 @default.

• next