PubMed · 14167523
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K YAMAKAWA, K KITAMURA, K MINAMITANI. 1964. [VARIOUS PROBLEMS WITH THE TELEMETER CIRCUIT].. https://pubmed.ncbi.nlm.nih.gov/14167523/
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BACKGROUND: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future. RESEARCH DESIGN AND METHODS: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations. RESULTS: The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalized their existing product portfolios and removed devices from the market as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff. CONCLUSION: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.
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INTRODUCTION: Operators of construction equipment perform various duties at work that expose them to a variety of risk factors that may lead to health problems. A few of the health hazards among operators of construction equipment are: (a) whole-body vibration, (b) awkward postural requirements (including static sitting), (c) dust, (d) noise, (e) temperature extremes, and (f) shift work. It has been suggested that operating engineers (OEs) are exposed to two important risk factors for the development of musculoskeletal disorders: whole-body vibration and non-neutral body postures. METHOD: This review evaluates selected papers that have studied exposure to whole-body vibration and awkward posture among operators of mobile equipment. There have been only few studies that have specifically examined exposure of these risk factors among operators of construction equipment. Thus other studies from related industry and equipment were reviewed as applicable. CONCLUSION: In order to better understand whole-body vibration and postural stress among OEs, it is recommended that future studies are needed in evaluating these risk factors among OEs.