Regulatory aspects of medical devices and biomaterials

2019 ◽  
pp. 23-36 ◽  
Author(s):  
Prabaha Sikder ◽  
Sarit B. Bhaduri
Keyword(s):  
Medical Devices ◽  
Regulatory Aspects

Medical devices regulatory aspects: a special focus on polymeric material based devices

2015 ◽  
Vol 21 (42) ◽  
pp. 6246-6259 ◽  
Author(s):  
Radhakrishnan Sridhar ◽  
Damian Pliszka ◽  
He-Kuan Luo ◽  
Keith Chin Lim ◽  
Seeram Ramakrishna
Keyword(s):  
Polymeric Material ◽  
Medical Devices ◽  
Special Focus ◽  
Regulatory Aspects

scholarly journals Considerations on D-mannose Mechanism of Action and Consequent Classification of Marketed Healthcare Products

2021 ◽  
Vol 12 ◽  
Author(s):  
Francesco Scaglione ◽  
Umberto M. Musazzi ◽  
Paola Minghetti
Keyword(s):  
Medical Devices ◽  
Bacterial Adhesion ◽  
Antibiotics Resistance ◽  
Adult Women ◽  
Urothelial Cells ◽  
Regulatory Aspects ◽  
Alternative Approach ◽  
Tract Infections ◽  
Adhesive Effect

Urinary tract infections (UTIs) are very common disorders that affect adult women. Indeed, 50% of all women suffer from UTIs at least one time in their lifetime; 20–40% of them experience recurrent episodes. The majority of UTIs seems to be due to uropathogenicEscherichia colithat invades urothelial cells and forms quiescent bacterial reservoirs. Recurrences of UTIs are often treated with non-prescribed antibiotics by the patients, with increased issues connected to antibiotics resistance. D-mannose, a monosaccharide that is absorbed but not metabolized by the human body, has been proposed as an alternative approach for managing UTIs since it can inhibit the bacterial adhesion to the urothelium. This manuscript discusses the mechanisms through which D-mannose acts to highlight the regulatory aspects relevant for determining the administrative category of healthcare products placed on the market. The existing literature permits to conclude that the anti-adhesive effect of D-mannose cannot be considered as a pharmacological effect and, therefore, D-mannose-based products should be classified as medical devices composed of substances.

scholarly journals Regulatory aspects of medical devices in India

2017 ◽  
Vol 9 (2) ◽  
pp. 18
Author(s):  
Monika Targhotra ◽  
Geeta Aggarwal ◽  
Harvinder Popli ◽  
Madhu Gupta
Keyword(s):  
Public Health ◽  
Medical Device ◽  
Medical Devices ◽  
Large Population ◽  
Regulatory Body ◽  
Design Development ◽  
Market Place ◽  
Safety Assurance ◽  
Regulatory Aspects ◽  
Regulatory Guidelines

<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p>

Global trends in circulation of medical devices

2019 ◽  
Vol 2019 (3) ◽  
pp. 21-23 ◽  
Author(s):  
Елена Астапенко ◽  
Elena Astapenko ◽  
Анна КОРТОШКИНА ◽  
Anna KORTOShKINA
Keyword(s):  
Medical Device ◽  
Russian Federation ◽  
Medical Devices ◽  
International Medical ◽  
Regulatory Environment ◽  
Global Trends ◽  
Regulatory Aspects ◽  
The Russian Federation

The article presents main tendencies in development of the legal and regulatory environment in circulation of medical devices in world’s major states. The article depicts major developed in regulatory aspects in countries members of the International Medical Device Regulators Forum (IMDRF) that took place in the late 2018 – early 2019, which are important for subjects of circulation of medical devices which planning their activities not only in the Russian Federation territory, but also abroad.

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

Self-Regulatory Aspects of Bullshitting and Bullshit Detection

2020 ◽  
Vol 51 (4) ◽  
pp. 239-253
Author(s):  
John V. Petrocelli ◽  
Haley F. Watson ◽  
Edward R. Hirt
Keyword(s):  
Evidence Based ◽  
Regulatory Aspects

Abstract. Two experiments investigate the role of self-regulatory resources in bullshitting behavior (i.e., communicating with little to no regard for evidence, established knowledge, or truth; Frankfurt, 1986 ; Petrocelli, 2018a ), and receptivity and sensitivity to bullshit. It is hypothesized that evidence-based communication and bullshit detection require motivation and considerably greater self-regulatory resources relative to bullshitting and insensitivity to bullshit. In Experiment 1 ( N = 210) and Experiment 2 ( N = 214), participants refrained from bullshitting only when they possessed adequate self-regulatory resources and expected to be held accountable for their communicative contributions. Results of both experiments also suggest that people are more receptive to bullshit, and less sensitive to detecting bullshit, under conditions in which they possess relatively few self-regulatory resources.

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