Post-market surveillance of medical devices: A review
BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare
system. Considering their importance in daily medical practice, the process of …
system. Considering their importance in daily medical practice, the process of …
Medical device development process, and associated risks and legislative aspects-systematic review
Objective: Medical device development, from the product's conception to release to market,
is very complex and relies significantly on the application of exact processes. This paper …
is very complex and relies significantly on the application of exact processes. This paper …
Fatigue testing of wearable sensing technologies: Issues and opportunities
Standards for the fatigue testing of wearable sensing technologies are lacking. The majority
of published fatigue tests for wearable sensors are performed on proof-of-concept stretch …
of published fatigue tests for wearable sensors are performed on proof-of-concept stretch …
[HTML][HTML] Development of new endovascular devices for aneurysm treatment
ZY Jia, HB Shi, S Miyachi, SM Hwang, JJ Sheen… - Journal of …, 2018 - ncbi.nlm.nih.gov
Since the first use of the Guglielmi detachable coil system for cerebral aneurysm
embolization in 1990, various endovascular methods have been developed to treat large …
embolization in 1990, various endovascular methods have been developed to treat large …
How do orthopaedic devices change after their initial FDA premarket approval?
Background The FDA approves novel, high-risk medical devices through the premarket
approval (PMA) process based on clinical evidence supporting device safety and …
approval (PMA) process based on clinical evidence supporting device safety and …
FDA device oversight from 1906 to the present
A Pisac, N Wilson - AMA Journal of Ethics, 2021 - journalofethics.ama-assn.org
This article examines the history of device oversight by the US Food and Drug
Administration (FDA). Significant regulatory changes occurred in response to injuries …
Administration (FDA). Significant regulatory changes occurred in response to injuries …
Introduction of novel medical devices in surgery: ethical challenges of current oversight and regulation
IS Muskens, S Gupta, A Hulsbergen… - Journal of the …, 2017 - journals.lww.com
SUMMARY OF CURRENT LEGISLATION Food and Drug Administration (FDA) and
Conformité Européenne (CE) are government bodies that are responsible for medical …
Conformité Européenne (CE) are government bodies that are responsible for medical …
[HTML][HTML] The importance of the learning process in ST analysis interpretation and its impact in improving clinical and neonatal outcomes
S Timonen, K Holmberg - American Journal of Obstetrics and Gynecology, 2018 - Elsevier
Background Intrapartum fetal heart rate monitoring was introduced with the goal to reduce
fetal hypoxia and deaths. However, continuous fetal heart rate monitoring has been shown …
fetal hypoxia and deaths. However, continuous fetal heart rate monitoring has been shown …
Biocompatibility, Bio-Clearance, and Toxicology
Biomaterials' biocompatibility has been a highly contentious topic for years. The
phenomenon's definite significance and underlying mechanisms of biomaterials still need to …
phenomenon's definite significance and underlying mechanisms of biomaterials still need to …
Minimal Access in Pediatric Surgery: An Overview on Progress towards Dedicated Instrument Developments and Anesthesiologic Advances to Enhance Safe …
G Pelizzo, F Destro, UM Pierucci, S Costanzo… - Children, 2024 - mdpi.com
Surgical techniques are evolving in Pediatric Surgery, especially in the area of minimal
access surgery (MAS) where indications for applications are expanding. Miniaturization of …
access surgery (MAS) where indications for applications are expanding. Miniaturization of …