Probleme beim Einkauf von Dienstleistungen (German Edition)
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Our investigation also showed that the number of apps that were explicitly mentioned as not being a medical device exceeded the number of apps for which there was a reference to quality-related seals or labels. Medical device status was explicitly excluded eight times in total which we believe to be valid based on the information given in the respective store descriptions , and there were only five references to seals or labels Table 1.
Two apps only referred to being listed on a website curated by experts, which although possibly being an alternative, may or may not provide users with the same level of confidence about quality as CE markings or established quality seals. The aim of this study was to provide an up-to-date overview of how official regulatory markings for medical devices, namely the CE marking applicable in Europe, and marks supposedly designating quality eg, quality seals are used in apps found on the market. This was done to investigate whether manufacturers prefer to publish apps that are subject to official regulation due to their functionality or whether they would rather limit themselves to apps that do not contain functions requiring adherence to medical device regulations and for which quality seals would therefore be sufficient.
App characteristics were also factored in to narrow down potential reasons for either alternative being preferred. However, manufacturers and providers seem to attach little importance to them. Reasons may be similar to those often given with respect to quality seals for websites, which are also used less frequently than expected.
Here too, seals of approval are fairly unknown, although there are many different seals that are potentially applicable in this context. Wetter [ 22 ] suspects that it is this considerable number of seals and the different approaches they stand for as well as the resulting competition among seal-awarding authorities that confuses those who have to decide which seal to apply for. The decision whether to apply for a seal or certification or to pursue another strategy to convince users of a product's quality remains open [ 22 ].
Whether quality seals assigned to websites actually give an indication of quality is also controversial. As was already shown by Keselman et al in [ 23 ], there is not always a connection between defined quality criteria being fulfilled and websites providing accurate content, and the same probably holds true in an app context. Therefore, it would be understandable if, especially for apps that are deemed medical devices, manufacturers and providers were to concentrate on advertising CE markings rather than quality seals, presumably also because this is already deemed sufficient with respect to marketing considerations in this context.
Beyond the perception of quality by users and how this perceived quality influences decisions to purchase and install apps within the secondary health care market, manufacturers are aware that obtaining a CE marking significantly increases or is presumed to increase chances of entering the primary and insurer-paid health care market. As a rule, a detailed quality check, which many users may expect, does not take place in this context. However, it can be stated that the conformity assessment procedure is at least transparent in its requirements and thus provides more information about what is to be expected than is the case with some providers of quality seals.
It may also be possible that the financial and time expenditure involved in obtaining a seal or other quality approval is an obstacle [ 26 , 27 ]. For apps for which this is a requirement, following regulation is just as time consuming and costly, and obtaining a seal is voluntary and may thus be foregone if manufacturers perceive no obvious benefit.
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Possibly, the fees usually in the range of several hundred to several thousand Euros often required for developers to be able to obtain these seals or approvals for their apps may be a deterrent as well; some are available for free, but others require either a one-time, monthly, or yearly fee or paid membership in an organization, which may be perceived as a continuing burden especially for apps with limited potential for commercial success.
However, there are some measures that may hold much lower thresholds for manufacturers while aiding potential users in their decisions. To provide future users with low-threshold, cost-neutral support, it would be conceivable to produce meaningful descriptions following a standardized structure that covers relevant information eg, about sources used for implementing the app, qualifications of those involved rather than only providing marketing phrases. This approach would provide users with relevant information they need to make purchase decisions and it would not be an undue burden—sometimes mentioned in the literature [ 30 ]—on developers because they should have the corresponding information at their fingertips.
Making such standardized reporting obligatory albeit without regularly performed mandatory checks by official bodies , similar to what is currently required with respect to an imprint [ 21 , 31 - 33 ], should certainly be discussed by all stakeholders. This would ensure that users are provided with relevant information before downloading.
Our study was subject to the following limitations. Our focus was specifically on the German-speaking region, reflected by the evaluation of apps for which German-language store descriptions had been provided. We also considered only quality initiatives and regulatory approaches relevant in the German-speaking regions, and we had to limit ourselves to app registrations found in the DIMDI database due to the fees required for searching in other regulatory databases.
For the future, with the introduction and adoption of unique device identifiers and the European Database on Medical devices, as required under medical device regulation, it will henceforth become easier to assess all medical devices, including apps, placed on the European market. Ongoing work, to be published later, also considers regulatory requirements eg, US Food and Drug Administration approval as well as seals found internationally to determine whether there are significant differences between geographic regions.
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Even though considerable effort was made to identify existing quality-related seals with a special focus on applicability in a health context, it cannot be ruled out that there are possible, probably recently established, initiatives we did not find. Of course, seal providers are also called on to not only publish information about what they offer but also to ensure that this information can be found using relevant search engines.
They should also take care to keep their information about validated apps up to date. In addition, we only used the description texts of the apps for our keyword-based searches. No statements can be made on the basis of this information about whether this actually reflects the information provided within the apps themselves or elsewhere. Another limitation of the work is its limitation to one single app store. The prevalence of labels in App Store descriptions is negligible. Therefore, it is reasonable to assume that these are not of any noteworthy relevance for manufacturers when it comes to providing information and promoting their products.
Only medical device designations are communicated regularly and in full, which does take account of the regulatory necessity, but also helps with differentiating them from other nonregulated and labeled products in terms of advertising effectiveness. To improve the quality-related information provided in the stores, a standardized reporting process used for compiling the app description text is recommended. A legal obligation to do so would contribute to the effective enforcement of appropriate information.
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Conflicts of Interest: None declared. National Center for Biotechnology Information , U. Published online Apr Reviewed by K Anderson and Michael Lang. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Corresponding Author: Urs-Vito Albrecht ed. This article has been cited by other articles in PMC. Conclusions Currently, quality seals seem to be irrelevant for manufacturers.
Keywords: mobile phone, mobile health app, quality assessment, quality seals, medical device regulation. Methods Overview To answer the aforementioned questions, a two-stage process was used. Search Strategy for Identifying App Seals Official test institutions specializing in health-related apps and their specific requirements, standardized and universally accepted testing procedures, or registers that list various approaches applicable in a health context are rare.
Open in a separate window. Figure 1. Identification of Apps With Definite Seal Assignments As an additional validation step, we also checked for a relationship between the seals actually awarded by various initiatives active in this business and their actual mention by manufacturers within the App Store descriptions. Table 1 Types and numbers of seals identified from the Web search stratified by primary category. Ich bin einverstanden, dass Movinga mich anruft, um Details zu besprechen und ein unverbindliches Angebot zu erstellen. Einfach Umziehen mit Movinga.
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