Impact of design on medical device safety

T Miclăuş, V Valla, A Koukoura, AA Nielsen… - … Innovation & Regulatory …, 2020 - Springer
The growing number of emerging medical technologies and sophistication of modern
medical devices (MDs) that improve both survival and quality of life indexes are often …

Medical device regulation: should we care about it?

E Bianchini, CC Mayer - Artery Research, 2022 - Springer
Medical devices are subject to strict regulatory and approval processes to enter the market
and to be used by operators and patients. These are needed to guarantee the users' safety …

Is medical device regulatory compliance growing as fast as extended reality to avoid misunderstandings in the future?

F Bini, M Franzò, A Maccaro, D Piaggio, L Pecchia… - Health and …, 2023 - Springer
Abstract Purpose European Extended Reality (XR) industry is expected to significantly
increase by 2025 with an extreme impact on the Healthcare scenario. Considering that the …

Implementation of a lean 4.0 project to reduce non-value add waste in a medical device company

I Foley, O McDermott, A Rosa, M Kharub - Machines, 2022 - mdpi.com
The fourth industrial revolution, also referred to as Industry 4.0, has resulted in many
changes within the manufacturing industry. The purpose of the study is to demonstrate how …

The impact of industry 4.0 on the medical device regulatory product life cycle compliance

O McDermott, I Foley, J Antony, M Sony, M Butler - Sustainability, 2022 - mdpi.com
The fourth industrial revolution, also referred to as Industry 4.0, has resulted in many
changes within the MedTech Industry. The MedTech industry is changing from …

Guidance for Clinical Evaluation under the Medical Device Regulation through Automated Scoping Searches

FSKB Tang, M Bukowski, T Schmitz-Rode, R Farkas - Applied Sciences, 2023 - mdpi.com
Featured Application The developed automated search methods can support medical
device manufacturers with a first orientation before the clinical evaluation for the European …

Expanding quality by design principles to support 3D printed medical device development following the renewed regulatory framework in Europe

L Adalbert, SPY Kanti, O Jójárt-Laczkovich, H Akel… - Biomedicines, 2022 - mdpi.com
The vast scope of 3D printing has ignited the production of tailored medical device (MD)
development and catalyzed a paradigm shift in the health-care industry, particularly …

Medical devices nomenclature systems: a scoping review

E Iadanza, S Cerofolini, C Lombardo, F Satta… - Health and …, 2021 - Springer
Inventory is a fundamental process throughout the life cycle of medical devices. The
maintenance program for each piece of equipment must comply with current regulations that …

Analysis of the regulatory, legal, and medical conditions for the prescription of mobile health applications in the United States, the European Union, and France

P Hassanaly, JC Dufour - Medical Devices: Evidence and …, 2021 - Taylor & Francis
Introduction Mobile health (mHealth) is now considered an important approach to extend
traditional health services and to meet the growing medical needs. The prescribability of …

Blockchain-Based Infrastructure for Product Traceability in the Medical Supply Chain

T Gürpinar, SRB Ashraf, N Broza-Abut… - Prospects of Blockchain …, 2022 - igi-global.com
This chapter introduces a blockchain-based infrastructure to support the traceability of
medical products and implementation of unique device identification. Therefore, in the next …