IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation

IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation

Bibliographic Details
Main Authors:	Peter McCulloch, Bruce Campbell, Camilla Fleetcroft
Format:	Article
Language:	English
Published:	BMJ Publishing Group 2021-06-01
Series:	BMJ Surgery, Interventions, & Health Technologies
Online Access:	https://sit.bmj.com/content/3/1/e000066.full

Similar Items

IDEAL-D: a rational framework for evaluating and regulating the use of medical devices
by: Sedrakyan, A, et al.
Published: (2016)

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

Implantable device regulation in Europe.
by: McCulloch, P, et al.
Published: (2012)

European Regulation of Medical Devices
by: Hodges, C
Published: (2009)

Innovation or regulation: IDEAL opportunity for consensus.
by: McCulloch, P, et al.
Published: (2010)

The IDEAL recommendations and urological innovation.
by: McCulloch, P
Published: (2011)

Challenges faced by manufacturers with clinical evaluation under the new European Medical Device Regulations
by: Breda Kearney, et al.
Published: (2023-12-01)

The Challenges of Setting Up a Clinical Study with the New European Union Medical Device Regulation
by: Sílvia Rêgo, et al.
Published: (2023-05-01)

Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
by: Schmidt Wolfram, et al.
Published: (2020-09-01)

Validated Wearable Device Shows Acute Postoperative Changes in Sleep Patterns Consistent With Patient-Reported Outcomes and Progressive Decreases in Device Compliance After Shoulder Surgery
by: Pranav V. Gadangi, B.S., et al.
Published: (2023-10-01)

Application of the IDEAL framework to robotic urologic surgery.
by: Dahm, P, et al.
Published: (2014)

The Regulation of Medicines and Medical Devices
by: Hodges, C
Published: (2011)

Rethinking medical device regulation.
by: Heneghan, C, et al.
Published: (2012)

Reflection of the Medical Device Regulation
by: Sojka Karolina, et al.
Published: (2023-09-01)

Progress in clinical research in surgery and IDEAL
by: McCulloch, P, et al.
Published: (2018)

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

No surgical innovation without evaluation: the IDEAL recommendations
by: McCulloch, M, et al.
Published: (2009)

Generating evidence for new high-risk medical devices
by: Bruce Campbell, et al.
Published: (2019-11-01)

Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?
by: Emilia Niemiec
Published: (2022-03-01)

Contraception, Fertility Tracking, and the Limits of Medical Devices Regulation
by: Catriona McMillan
Published: (2023-11-01)

REGULATION OF MEDICAL DEVICES Initiative in anaesthesia
by: Pandit, J
Published: (2011)

Medical devices : surgical and image-guided technologies /
by: Culjat, Martin, 1977- 541382, et al.
Published: (c201)

Guide to microbiological control in pharmaceuticals and medical devices /
by: Denyer, Stephen P., et al.
Published: (2007)

The Medical Device Regulation and its impact on device development and research in Germany
by: Mark E. Ladd
Published: (2023-11-01)

Economic Tendencies of the European and Latvian Medical Device Market
by: Semjonova Nadezhda
Published: (2020-02-01)

Medical Devices: Regulation, Risk Classification, and Open Innovation
by: Lukas Peter, et al.
Published: (2020-06-01)

The evolution of medical device regulation in Taiwan: From the pharmaceutical affairs act to the medical devices act
by: Kuo-Li Lee, et al.
Published: (2024-04-01)

Unforeseen side-effects of the novel regulation of non-medical brain stimulation devices in the European Union
by: Jan Christoph Bublitz
Published: (2023-05-01)

Development and manufacturing of a custom made implant regarding the new European Medical Device Regulation
by: Schonhoff Mareike, et al.
Published: (2019-09-01)

Self-consistent noise characterization of quantum devices
by: Sun, Won Kyu Calvin, et al.
Published: (2023)

On the universality of medical device regulations: the case of Benin
by: A. Maccaro, et al.
Published: (2022-08-01)

Design of supply regulators for portable medical devices
by: Zhou, Ao
Published: (2022)

Regulation 2017/745 on medical devices, two major innovations: 1) the physiological action of devices consisting of natural materials such as vegetal matrices; 2) the chemical-physical-mechanical action of devices made of “substances”, which as such are artificial derivatives
by: Marcella Marletta, et al.
Published: (2024-04-01)

How can we improve surgical research and innovation?: the IDEAL framework for action.
by: Hirst, A, et al.
Published: (2013)

How can we improve surgical research and innovation?: The IDEAL framework for action
by: Hirst, A, et al.
Published: (2013)

The Shape of Medical Devices Regulation in the United Kingdom? Brexit and Beyond
by: Muireann Quigley, et al.
Published: (2023-11-01)

User Based Design of Medical Devices for Translation from Prototype to Clinical Device
by: Montague-Alamin, Healey
Published: (2022)

IDEAL framework for surgical innovation 1: the idea and development stages.
by: McCulloch, P, et al.
Published: (2013)

Surgical Innovation and Evaluation 3 No surgical innovation without evaluation: the IDEAL recommendations
by: McCulloch, P, et al.
Published: (2009)

A Practical Guide to Class IIa Medical Device Development
by: Adél Hinsenkamp, et al.
Published: (2020-05-01)