IDEAL-D: a rational framework for evaluating and regulating the use of medical devices

IDEAL-D: a rational framework for evaluating and regulating the use of medical devices

High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

Библиографические подробности
Главные авторы:	Sedrakyan, A, Campbell, B, Merino, J, Kuntz, R, Hirst, A, McCulloch, P
Формат:	Journal article
Язык:	English
Опубликовано:	BMJ Publishing Group 2016

Схожие документы

Application of the IDEAL framework to robotic urologic surgery.
по: Dahm, P, и др.
Опубликовано: (2014)

IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation
по: Peter McCulloch, и др.
Опубликовано: (2021-10-01)

Implantable device regulation in Europe.
по: McCulloch, P, и др.
Опубликовано: (2012)

How can we improve surgical research and innovation?: The IDEAL framework for action
по: Hirst, A, и др.
Опубликовано: (2013)

How can we improve surgical research and innovation?: the IDEAL framework for action.
по: Hirst, A, и др.
Опубликовано: (2013)

The EU's system for regulating medical devices.
по: McCulloch, P
Опубликовано: (2012)

No surgical innovation without evaluation: evolution and further development of the IDEAL framework and recommendations
по: Hirst, A, и др.
Опубликовано: (2018)

IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage.
по: Cook, J, и др.
Опубликовано: (2013)

Innovation or regulation: IDEAL opportunity for consensus.
по: McCulloch, P, и др.
Опубликовано: (2010)

Evidence-based evaluation of practice and innovation in physical therapy using the IDEAL-Physio framework
по: Beard, D, и др.
Опубликовано: (2017)

Evidence based evaluation of practice using the ideal-physio framework. A strategic method of evaluating innovation and current practice
по: Beard, D, и др.
Опубликовано: (2017)

Identifying research waste from surgical research: a protocol for assessing compliance with the IDEAL framework and recommendations
по: Xin Sun, и др.
Опубликовано: (2021-10-01)

The IDEAL recommendations and urological innovation.
по: McCulloch, P
Опубликовано: (2011)

Robotic surgery: revisiting "no innovation without evaluation".
по: Paul, S, и др.
Опубликовано: (2013)

Hey, I Just Did a Better Operation! Toward an IDEAL Innovation Model
по: Sood, A, и др.
Опубликовано: (2017)

COVID-19 has no effect on gravity
по: Peter McCulloch, и др.
Опубликовано: (2020-12-01)

Lighting a candle
по: Peter McCulloch, и др.
Опубликовано: (2019-11-01)

IDEAL framework for surgical innovation 1: the idea and development stages.
по: McCulloch, P, и др.
Опубликовано: (2013)

IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages.
по: Ergina, P, и др.
Опубликовано: (2013)

No surgical innovation without evaluation: the IDEAL recommendations
по: McCulloch, M, и др.
Опубликовано: (2009)

No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework
по: Bolton, WS, и др.
Опубликовано: (2024)

Maturity framework and select approaches for developing Coordinated Registry Networks (CRNs): Medical Device Epidemiology Network (MDEpiNet) supplement
по: Art Sedrakyan, и др.
Опубликовано: (2022-11-01)

Surgical Innovation and Evaluation 3 No surgical innovation without evaluation: the IDEAL recommendations
по: McCulloch, P, и др.
Опубликовано: (2009)

Electronic health data quality maturity model for medical device evaluations
по: Art Sedrakyan, и др.
Опубликовано: (2020-11-01)

The IDEAL prospective development study format for reporting surgical innovations. An illustrative case study of robotic oesophagectomy
по: Diez Del Val, I, и др.
Опубликовано: (2015)

Progress in clinical research in surgery and IDEAL
по: McCulloch, P, и др.
Опубликовано: (2018)

Are the Ideals of Rationality Rational? On the Experimenter’s Regress, the Theoretician’s Regress, and the Epistemologist’s Progress
по: Olga E. Stoliarova
Опубликовано: (2024-03-01)

Evolution of transanal total mesorectal excision according to the IDEAL framework
по: Willem A Bemelman, и др.
Опубликовано: (2019-07-01)

Formal Rationality as Ideal: The Textbook Approach to Management
по: Karin Brunsson
Опубликовано: (2022-09-01)

Long-term active surveillance of implantable medical devices: an analysis of factors determining whether current registries are adequate to expose safety and efficacy problems
по: Art Sedrakyan, и др.
Опубликовано: (2019-11-01)

The molecular genetics of insulin secretion and signalling
по: McCulloch, L, и др.
Опубликовано: (2011)

No surgical innovation without evaluation: the IDEAL recommendations.
по: McCulloch, P, и др.
Опубликовано: (2009)

Wanted: An appropriate evaluation template
по: McCulloch, P
Опубликовано: (2011)

Wanted: an appropriate evaluation template.
по: McCulloch, P
Опубликовано: (2011)

The effects of aviation-style non-technical skills training on technical performance and outcome in the operating theatre.
по: McCulloch, P, и др.
Опубликовано: (2009)

Big Issues on Small Polyps: An Ideal Device, But Is It for an Ideal Indication?
по: Yoji Takeuchi
Опубликовано: (2021-05-01)

Quest for an Ideal Intubating Device
по: Goneppanavar Umesh
Опубликовано: (2012-03-01)

Assessing the development status of intraoperative fluorescence imaging for anatomy visualisation, using the IDEAL framework
по: Peter McCulloch, и др.
Опубликовано: (2022-03-01)

One-fibered ideals in 2-dimensional rational singularities that can be desingularized by blowing up the unique maximal ideal
по: Lierde Veronique
Опубликовано: (2011-12-01)

EVALUATION OF DRUG ADVERTISEMENTS IN A MEDICAL JOURNALThough ideally the scientific information provided by pharmaceutical companies in drug advertisements should be for promotion of rational use of drugs, this objective is rarely achieved, as often the d
по: Harmeet Singh Rehan, и др.
Опубликовано: (2003-10-01)