Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.
Sign Up to like & getrecommendations! Published in 2021 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2021.3942
Abstract: Importance In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database.… read more here.
Keywords: event reports; death; adverse event; medical device ... See more keywords
Advancing Equity in Medical Device Development for Children.
Sign Up to like & getrecommendations! Published in 2023 at "JAMA pediatrics"
DOI: 10.1001/jamapediatrics.2023.0790
Abstract: This Viewpoint reviews activities to increase pediatric medical device development, assesses ongoing challenges, and recommends strategies to strengthen pediatric programs. read more here.
Keywords: medical device; device development; equity medical; advancing equity ... See more keywords
Enabling MedTech Translation in Academia: Redefining Value Proposition with Updated Regulations.
Sign Up to like & getrecommendations! Published in 2020 at "Advanced healthcare materials"
DOI: 10.1002/adhm.202001237
Abstract: Academic institutions are becoming more focused on translating new technologies for clinical applications. A transition from "bench to bedside" is often described to take basic research concepts and methods to develop a therapeutic or diagnostic… read more here.
Keywords: medtech translation; translation; translation academia; medical device ... See more keywords
The Fall Out of the 2017 European Medical Device Regulation for Tracheal Occlusion
Sign Up to like & getrecommendations! Published in 2025 at "Prenatal Diagnosis"
DOI: 10.1002/pd.6763
Abstract: The use of the Balt Goldbal‐balloon and Baltacci‐catheter in Fetoscopic Endoluminal Tracheal Occlusion is affected by the 2017‐European Medical Device Regulation, which necessitates recertification even for devices long considered safe. This regulation has led the… read more here.
Keywords: 2017 european; tracheal occlusion; device regulation; medical device ... See more keywords
Mobile medical app development with a focus on traceability
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Software: Evolution and Process"
DOI: 10.1002/smr.1861
Abstract: Today, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers need to understand what is… read more here.
Keywords: mobile medical; application; development; medical device ... See more keywords
Artificial Intelligence, data protection and medical device regulations: squaring the circle with a historical perspective in Europe
Sign Up to like & getrecommendations! Published in 2024 at "Health and Technology"
DOI: 10.1007/s12553-024-00878-z
Abstract: This manuscript presents a parallel among important EU legal frameworks, such as the Medical Device Regulations and General Data Protection Regulation and economic-historical challenges faced by European citizens. This parallel offers a prospective for understanding… read more here.
Keywords: data protection; device regulations; medical device; steel ... See more keywords
Medical Devices: Classification and Analysis of Faults Leading to Harms
Sign Up to like & getrecommendations! Published in 2019 at "Drug Safety"
DOI: 10.1007/s40264-019-00879-2
Abstract: Introduction Harms from medical devices are important, but have been much less well studied than adverse drug reactions. Information provided to device users is of variable quality. Objective Our aim was to define “medical device… read more here.
Keywords: use; harms medical; device; medical device ... See more keywords
Human factors in the design of medical devices - Approaches to meeting international standards in the European Union and USA.
Sign Up to like & getrecommendations! Published in 2017 at "Applied ergonomics"
DOI: 10.1016/j.apergo.2016.08.034
Abstract: This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process… read more here.
Keywords: international standards; factors design; development; medical device ... See more keywords
Evaluation of the unique device identification system and an approach for medical device tracking
Sign Up to like & getrecommendations! Published in 2017 at "Health policy and technology"
DOI: 10.1016/j.hlpt.2017.04.003
Abstract: Abstract Background Most countries have different registration and tracking system, but unique device identification based approach was recently introduced in the USA. In 2013, FDA and EU released regulations about unique device identification system. In… read more here.
Keywords: system; unique device; device identification; medical device ... See more keywords
The novel application of tourniquet for reducing medical device-related pressure on ears
Sign Up to like & getrecommendations! Published in 2020 at "Journal of the American Academy of Dermatology"
DOI: 10.1016/j.jaad.2020.08.106
Abstract: Capsule summary: In this article, we try to apply a tourniquet to reduce medical device-related pressure injuries on ears, it is very practical, cost-effective and convenient when wearing ear-looped face masks and spectacles for a… read more here.
Keywords: novel application; device related; medical device; related pressure ... See more keywords
An international vascular registry infrastructure for medical device evaluation and surveillance.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of vascular surgery"
DOI: 10.1016/j.jvs.2017.01.020
Abstract: The Medical Device Epidemiology Network (MDEpiNet) is an innovative effort supported by the US Food and Drug Administration (FDA) that is committed to the development of a medical device science an ... read more here.
Keywords: registry infrastructure; vascular registry; international vascular; infrastructure medical ... See more keywords