Do regulatory changes seriously affect the medical devices industry? Evidence from the Czech Republic

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to "non-medical" products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.Web of Science9art. no. 66645

Forest leaf litter beetles of Taiwan: first DNA barcodes and first insight into the fauna

We report the publication of 953 DNA barcodes of forest leaf litter beetles from central Taiwan, in total representing 334 spe- cies of 36 beetle families. This is the first bulk of data from the Taiwanese Leaf Litter beetles project focused on uncovering the under-explored diversity of leaf litter beetles across Taiwan. Based on these data, we provide the first records of the following taxa for Taiwan: family Sphindidae (genus Aspidiphorus Ziegler, 1821); tribes Trichonychini, Ctenistini, and Bythinoplectini (all Staphylinidae: Pselaphinae); genera Gyrelon Hinton, 1942, Thyroderus Sharp, 1885, Cautomus Sharp, 1885 (all Cerylonidae), Dermatohomoeus Hlisnikovský, 1963 (Leiodidae), Paraploderus Herman, 1970 (Staphylinidae: Oxytelinae), Thinocharis Kraatz, 1859 (Staphylinidae: Paederinae), Cephennodes Reitter, 1884, Napoconnus Franz, 1957 (both Staphylinidae: Scydmaeninae), Bicava Belon, 1884 (Latridiidae), Otibazo Morimoto, 1961, Seleuca Pascoe, 1871 and Acallinus Morimoto, 1962 (all Curculioni- dae); species Oodes (Lachnocrepis) japonicus (Bates, 1873) (Carabidae: Licininae), Drusilla obliqua (Bernhauer, 1916) (Staphylin- idae: Aleocharinae) and Coccotrypes advena Blandford, 1894 (Curculionidae: Scolytinae). The records of Anapleus Horn, 1873 (Histeridae) and Batraxis Reitter, 1882 (Staphylinidae: Pselaphinae) have been confirmed. The male of Sivacrypticus taiwanicus Kaszab, 1964 (Archeocrypticidae) is described for the first time. Gyrelon jenpani Hu, Fikáček & Matsumoto, sp. nov. (Cerylon- idae) is described, illustrated, and compared with related species. DNA barcodes associated larvae of 42 species with adults, we are concisely illustrating some of these: Oodes japonicus, Perigona cf. nigriceps Dejean, 1831 (both Carabidae), Ptilodactyla sp. (Ptilodactylidae), Maltypus ryukyuanus Wittmer, 1970 (Cantharidae), Drusilla obliqua, Myrmecocephalus brevisulcus (Pace, 2008), Diochus sp., Mimopinophilus sp. (all Staphylinidae), Stelidota multiguttata Reitter, 1877, Lasiodites inaequalis (Grouvelle, 1914) (both Nitidulidae), Lagria scutellaris Pic, 1910, and Anaedus spinicornis Kaszab, 1973 (both Tenebrionidae). We also report the first cases of Rickettsia infections in Scydmaeninae and Pselaphinae. All data (sequences, metadata, and voucher photos) are made public in BOLD database and in a Zenodo Archive

Vegetation of Europe: hierarchical floristic classification system of vascular plant, bryophyte, lichen, and algal communities

Vegetation classification consistent with the Braun-Blanquet approach is widely used in Europe for applied vegetation science, conservation planning and land management. During the long history of syntaxonomy, many concepts and names of vegetation units have been proposed, but there has been no single classification system integrating these units. Here we (1) present a comprehensive, hierarchical, syntaxonomic system of alliances, orders and classes of Braun-Blanquet syntaxonomy for vascular plant, bryophyte and lichen, and algal communities of Europe; (2) briefly characterize in ecological and geographic terms accepted syntaxonomic concepts; (3) link available synonyms to these accepted concepts; and (4) provide a list of diagnostic species for all classes. Location: European mainland, Greenland, Arctic archipelagos (including Iceland, Svalbard, Novaya Zemlya), Canary Islands, Madeira, Azores, Caucasus, Cyprus. Methods: We evaluated approximately 10 000 bibliographic sources to create a comprehensive list of previously proposed syntaxonomic units. These units were evaluated by experts for their floristic and ecological distinctness, clarity of geographic distribution and compliance with the nomenclature code. Accepted units were compiled into three systems of classes, orders and alliances (EuroVegChecklist, EVC) for communities dominated by vascular plants (EVC1), bryophytes and lichens (EVC2) and algae (EVC3). Results: EVC1 includes 109 classes, 300 orders and 1108 alliances; EVC2 includes 27 classes, 53 orders and 137 alliances, and EVC3 includes 13 classes, 24 orders and 53 alliances. In total 13 448 taxa were assigned as indicator species to classes of EVC1, 2087 to classes of EVC2 and 368 to classes of EVC3. Accepted syntaxonomic concepts are summarized in a series of appendices, and detailed information on each is accessible through the software tool EuroVegBrowser. Conclusions: This paper features the first comprehensive and critical account of European syntaxa and synthesizes more than 100 yr of classification effort by European phytosociologists. It aims to document and stabilize the concepts and nomenclature of syntaxa for practical uses, such as calibration of habitat classification used by the European Union, standardization of terminology for environmental assessment, management and conservation of nature areas, landscape planning and education. The presented classification systems provide a baseline for future development and revision of European syntaxonomy.info:eu-repo/semantics/publishedVersio

EUNIS Habitat Classification: Expert system, characteristic species combinations and distribution maps of European habitats

Aim: The EUNIS Habitat Classification is a widely used reference framework for European habitat types (habitats), but it lacks formal definitions of individual habitats that would enable their unequivocal identification. Our goal was to develop a tool for assigning vegetation‐plot records to the habitats of the EUNIS system, use it to classify a European vegetation‐plot database, and compile statistically‐derived characteristic species combinations and distribution maps for these habitats. Location: Europe. Methods: We developed the classification expert system EUNIS‐ESy, which contains definitions of individual EUNIS habitats based on their species composition and geographic location. Each habitat was formally defined as a formula in a computer language combining algebraic and set‐theoretic concepts with formal logical operators. We applied this expert system to classify 1,261,373 vegetation plots from the European Vegetation Archive (EVA) and other databases. Then we determined diagnostic, constant and dominant species for each habitat by calculating species‐to‐habitat fidelity and constancy (occurrence frequency) in the classified data set. Finally, we mapped the plot locations for each habitat. Results: Formal definitions were developed for 199 habitats at Level 3 of the EUNIS hierarchy, including 25 coastal, 18 wetland, 55 grassland, 43 shrubland, 46 forest and 12 man‐made habitats. The expert system classified 1,125,121 vegetation plots to these habitat groups and 73,188 to other habitats, while 63,064 plots remained unclassified or were classified to more than one habitat. Data on each habitat were summarized in factsheets containing habitat description, distribution map, corresponding syntaxa and characteristic species combination. Conclusions: EUNIS habitats were characterized for the first time in terms of their species composition and distribution, based on a classification of a European database of vegetation plots using the newly developed electronic expert system EUNIS‐ESy. The data provided and the expert system have considerable potential for future use in European nature conservation planning, monitoring and assessment

Distribution maps of vegetation alliances in Europe

Aim: The first comprehensive checklist of European phytosociological alliances, orders and classes (EuroVegChecklist) was published by Mucina et al. (2016, Applied Vegetation Science, 19 (Suppl. 1), 3–264). However, this checklist did not contain detailed information on the distribution of individual vegetation types. Here we provide the first maps of all alliances in Europe. Location: Europe, Greenland, Canary Islands, Madeira, Azores, Cyprus and the Caucasus countries. Methods: We collected data on the occurrence of phytosociological alliances in European countries and regions from literature and vegetation-plot databases. We interpreted and complemented these data using the expert knowledge of an international team of vegetation scientists and matched all the previously reported alliance names and concepts with those of the EuroVegChecklist. We then mapped the occurrence of the EuroVegChecklist alliances in 82 territorial units corresponding to countries, large islands, archipelagos and peninsulas. We subdivided the mainland parts of large or biogeographically heterogeneous countries based on the European biogeographical regions. Specialized alliances of coastal habitats were mapped only for the coastal section of each territorial unit. Results: Distribution maps were prepared for 1,105 alliances of vascular-plant dominated vegetation reported in the EuroVegChecklist. For each territorial unit, three levels of occurrence probability were plotted on the maps: (a) verified occurrence; (b) uncertain occurrence; and (c) absence. The maps of individual alliances were complemented by summary maps of the number of alliances and the alliance–area relationship. Distribution data are also provided in a spreadsheet. Conclusions: The new map series represents the first attempt to characterize the distribution of all vegetation types at the alliance level across Europe. There are still many knowledge gaps, partly due to a lack of data for some regions and partly due to uncertainties in the definition of some alliances. The maps presented here provide a basis for future research aimed at filling these gaps

Quality control in construction firm GEOSAN GROUP Inc.

katedra: KPE; rozsah: 73 s., 3 s. přílohMy thesis is describing quality management systems (QMS) and environmental management system (EMS) in construction company GEOSAN GROUP Inc. and is simultaneously focused on archiving in the company. In the first part of my thesis are totally summarized processes and activities necessary for effective functioning of particular management systems. Quality management system divides into several parts, from documents and records management, to records required by ČSN EN ISO 9001 standard. Environmental management system (EMS) or environmental protection includes planning, operation management, control and review by the management of company. Separate chapter in my thesis is devoted to archiving. The current status of archiving is described and supplemented by a few pictures. For better picture of content and complexity of archiving is my thesis supplemented by filing and shredding code of the company. There is described the whole archiving process from document marking over document saving until document shredding. In the last part of my thesis, the present status of archiving is evaluated and solution including economic evaluation is suggested. From my thesis results insufficient capacity status of space designated for archiving and it is recommended to use modern method of electronic archiving.Diplomová práce popisuje systémy řízení jakosti a EMS ve stavební společnosti GEOSAN GROUP a.s. a současně je zaměřena na archivaci ve společnosti. V první části jsou komplexně shrnuty procesy a činnosti potřebné pro efektivní fungování jednotlivých systémů řízení. Systém řízení jakosti se dělí do několika částí, od řízení dokumentů a záznamů, až po záznamy požadované normou ČSN EN ISO 9001. Systém řízení EMS, neboli ochrana životního prostředí, zahrnuje plánování, řízení provozu, kontrolu a přezkoumání vedením organizace. Archivací ve společnosti se zabývá samostatná kapitola. Současný stav archivace je popsán a doplněn několika obrázky. Pro lepší představu obsahu a složitosti archivace je diplomová práce doplněna spisovým a skartačním řádem společnosti. Je zde popsán celý proces archivace od označení písemností, přes uložení, až po skartaci písemností. Poslední část hodnotí současný stav archivace a navrhuje řešení včetně ekonomické zhodnocení. Z diplomové práce vyplývá kapacitně nedostačující stav prostorů určených pro archivaci a je doporučeno využít moderní způsob elektronické archivace

Design of power supply and distribution of elektricity for the new site of the family home

Předkládaná diplomová práce řeší připojení nové lokality s plánovanou výstavbou 45 nových RD k Distribuční soustavě elektrické energie. V teoretické části práce jsou popsány základní postupy, kritéria a předpoklady pro návrh technického řešení připojení odběrných míst k DS. V další části práce je již zpracováno samotné technické řešení rozvodů elektrické energie ve dvou variantách (pro stupeň elektrizace A, a pro stupeň elektrizace C). V poslední části práce je porovnání a vyhodnocení obou návrhů technického řešení. Technické řešení obsahuje návrh distribuční stanice (DTS), návrh přípojky vedení vn k DTS, návrh rozvodů nn pro připojení 45 RD a návrh jištění sítě nn.Katedra elektroenergetiky a ekologieObhájenoThis master thesis addresses the connection of a new site with the planned construction of 45 new houses to the electric power grid. The theoretical part describes the basic procedures, criteria and conditions for the proposed technical solution for connecting customers to the distribution system. Another part of the thesis addresses the technical distributions solutions electric power in two variants (for grade electrification A, and for grade electrification C). The last part is to comparisons and evaluates these two proposals of technical solutions. The technical solution includes a proposal distribution station, proposal connection to the electric power grid MV, proposal wiring electric power grid LV to connect 45 RD and proposal protection network LV