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  • ReimbuRsement of medical devices in GeRmany

    2015-6-12 · Medical device manufacturers in Germany have to face an established, stable healthcare system, ... largest community of organizations bearing the costs and is of central importance for the German market for medical devices. Besides, it also has a major impact on reimbursements.

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  • Special requirements regarding placing medical

    2015-7-17 · mark can be placed on the market or put into service in Germany. However, there are special prerequisites concerning the first placing on the market in Germany. 'First placing on the market' is the first making available in return for payment or free of charge of a medical device to others in the European Economic

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  • Medical Device Regulations in Germany |

    Medical Pro, based in Germany, specialises in the sales of medical technology and practical accessories, as well as personal protective equipment (PPE). With 1100 subsidiaries and six listed companies, the...

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  • Medical devices Germany | Europages

    2015-5-9 · and gain the latest insights into medical device reprocessing. The principle topic ... very long period of time bearing in mind the rapid developments seen in the EDP sector. Therefore one has to ensure that ... Medical Device Reprocessing in Germany – 17 years of Medical Devices Act DGSV Congress, 7 – 9 …

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  • Medical Device Reprocessing in Germany – 17 years of

    2018-5-2 · New medical devices are difficult to introduce due to the strict approval processes. Devices must be listed on the EBM and G-DRG to be prescribed, and these catalogues are based on old empirical data. This time lag hampers a new device’s use in the market. Solutions: Inpatient

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  • The Reimbursement Environment for Medical

    Medical Device Registration and Approval in Germany General country-specific regulatory information is provided on this page for medical device registration and approval in Germany. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Germany, to expedite …

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  • Germany Medical Device Registration - BfArM and

    2017-12-15 · Example, 70% of medical technology products made in Germany were exported to international markets in 2016. Today, German is the world’s third-largest manufacturing market for medical devices with a share of 10.2 % of the worldwide pharmaceutical technology invention, after the United States (39%) and Japan (6. …

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  • Medical Device Regulations in Germany | Operon

    Markets Germany Germany’s market for medical technology – worth EUR 38 billion in 2019 – was already one of the largest in the world before the coronavirus. But the arrival of Covid-19 brought exponential growth in demand for German medical …

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  • Bearing Application In The Medical Industry

    2021-4-23 · The bearing product plays an important role in this kind of high precision equipment. In recent years, the demand for medical devices in the global market grows rapidly. With the miniature and high-precision requirements for such facilities, bearing products applied are strictly required to be with high speed, …

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  • Medical system has patient bearing device and

    Patent: Document Laid open (First Publication) - Germany. Application: DE200810032001 on 2008-07-07. Publication: 2010-01-21. Abstract. The medical system has a patient bearing device, and an imaging radiology therapy and examining unit with a medium for storing sequence parameter sets of the patient bearing device and radiological device…

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  • Vibrasat - Möller Medical GmbH

    Vibrasat ® Pro is the technologically leading vibration device for liposuction; Up to 5.000 strokes/min with a stroke of 2.8 mm; Power boost function (short-term increase of the vibration frequency) up to 6.000 strokes/min; Device operation by means of a button on the handle (vibration on off) Anatomically shaped device …

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  • Medical Device Reprocessing in Germany – 17 years

    2015-5-9 · operators of medical device reprocessing premises also have responsibilities in that respect. For example, the operator can not hold the manufacturer responsible for mistakes made during medical device repairs or reprocessing. That is also one of the main reasons for compiling the German Medical …

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  • Linear bearing device as a solution for optical

    Linear bearing device as a solution for optical navigation of fine needle procedures. Stüber V(1), Suero EM, H U Fner T, Wiewiorski M, Krettek C, Citak M. Author information: (1)Trauma Department, Hannover Medical School, Hannover, Germany. [email protected]

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  • OsteoFab® Medical Devices - Homepage | OPM

    OsteoFab ® Patient Specific Facial Device (OPSFD). The OsteoFab ® Patient Specific Facial Device (OPSFD) is individually designed for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of …

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  • Boca Bearings :: Ceramic Bearing Specialists

    Boca Bearings is the leader in Ceramic and Ceramic Hybrid bearing technology for industrial and recreational applications.

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  • Medical Equipment & Device Industry Market

    2021-5-10 · Global Medical Device Market Research. As with most industries, the global medical device industry (a segment of the healthcare industry) was not untouched by the economic crisis, though it has not deterred the industry’s overall growth.Smaller firms, unable to pick up the slack of product development costs …

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  • Medical Device Directive 93/42/EEC | TÜV SÜD

    The Medical Device Regulation (MDR) has entered into force on May 26th 2017. The MDR will replace the current EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently approved medical devices will have a transition time …

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  • Medical Device Technologies Market by Device

    Medical Device Technologies Market: Segmentation . The medical device technologies market has segmented into three categories, namely by device by end-user and by region. Geographically, the global Medical device technologies market has been segmented into five regions: North America, Europe, Asia …

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  • STEINCO | Manufacturer of swivel-, twin wheel &

    Double swivel castor, Housing made of polyamide, swivel bearing with precision ball bearing, colour: RAL 9002 - Grey white Locking device with total lock, centrally operated Wheel with ball bearing and non-marking grey polyurethane tyres (TPU) Connection via stem Ø32x50mm switching profile horizontal

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  • Whitepapers and Articles | Medical Devices | BSI

    BSI Medical device whitepapers will keep you up to date with regulations, ... Germany Deutsch > Ireland English > ... and to examine the scope for bioprinting processes to enhance medical devices, bearing in mind the lessons learnt from the more established 3D printing industry.

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  • OsteoFab® Medical Devices - Homepage | OPM

    OsteoFab ® Patient Specific Facial Device (OPSFD). The OsteoFab ® Patient Specific Facial Device (OPSFD) is individually designed for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of …

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  • Systems and Procedure Packs: Regulatory

    European jurisprudence consists of, firstly, the medical device directives that have to be transposed into national (medical device) law, and the EU medical device regulations (MDR, IVDR).This section describes the regulatory requirements that manufacturers who market systems or procedure packs must comply with.

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  • Finland Medical Device Registration - VALVIRA

    3) Sterilizes systems, procedure packs or medical devices bearing a CE marking. An authorized representative established in Finland is required to submit a similar notification. Manufacturers are obliged to notify all devices deemed to be high-risk, including IVD’s intended for self-testing and devices containing substances of …

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  • LIAONING AIMU MEDICAL SCIENCE &

    Up to now, there are more than 16 million women of child-bearing age have applied AiMu IUD. In 2006, Liaoning AiMu Medical Science & Technology Co., Ltd invested 16 million for the foundation of Beijing AiMu Medical Science & Technology Co., Ltd for Family Planning, and Camity Medical Technology Co., Ltd.

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  • Ireland Medical Device Registration - HPRA

    Medical Device Registration and Approval in Ireland General country-specific regulatory information is provided on this page for medical device registration and approval in Irelnad. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Ireland, to expedite …

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  • SmartCheck | Schaeffler Germany

    2021-4-8 · The integrated bearing database can be accessed when using the parameter presets. The presets can be easily adapted to the specific monitoring tasks with the aid of assistants. If requested by the customer, the Schaeffler Group will add user-specific parameter presets and make them available to the user.

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  • Industry Insight Ooh La Labeling: Device Labeling In

    2010-4-20 · development of medical device labeling in the EU. Compliance with labeling requirements is a formidable task for medical device companies. The penalties for non-compliance can be severe and range from delays in product commercialization to confiscation of goods and the levying of monetary fines. Herein we examine the medical device …

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  • ECRIN Medical Device Outcome Measure Database

    Outcome Measure: Primary- Number of women cured, number of women cured or improved (this outcome is henceforth referred to in the text as improvement), adverse events, condition-specific (and generic measures of health-related) quality of life, Secondary - Quantification of symptoms (number of incontinent episodes …

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  • Medical Device Technology - ziehl-abegg.com

    A pioneering drive type that is suitable for many applications in the field of medical device technology is the direct drive. The motor transmits its speed and torque directly to the motor shaft and the device – in the case of a CT scanner, for example, to the scanner unit that is to be moved – without a gearbox and it is therefore …

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  • Systems and Procedure Packs: Regulatory

    European jurisprudence consists of, firstly, the medical device directives that have to be transposed into national (medical device) law, and the EU medical device regulations (MDR, IVDR).This section describes the regulatory requirements that manufacturers who market systems or procedure packs must comply with.

    Get Price
  • Tidda AI Zana earns medical device CE mark Europe

    Zana Technologies GmbH (Zana), a German-based digital health company, announces that it has received the Class I Medical Device CE Mark for its Artificial Intelligence-supported health monitoring platform Tidda AI.. The CE certification mark assures that Tidda AI, which is the flagship product of Zana Technologies, conforms to the stringent requirements of the Medical …

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  • Medical Device Companies in Israel - Israel Exporter

    LifeCan Medical has developed a device that converts a standard manual BVM respirator into an automatic ventilator. The device was developed with a combination of engineers, doctors, quality and regulation personnel.

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  • Condition Monitoring With Digital Ultrasonic

    The extensive software and accessories available enable these devices to be used for a multitude of applications. With bearing testing, the ultrasonic testing device SONAPHONE can be used to check lubrication and friction levels, interpret defect induced noises, and in the case of rotary pumps, detect cavitation.

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  • Industry Insight Ooh La Labeling: Device Labeling In

    2010-4-20 · development of medical device labeling in the EU. Compliance with labeling requirements is a formidable task for medical device companies. The penalties for non-compliance can be severe and range from delays in product commercialization to confiscation of goods and the levying of monetary fines. Herein we examine the medical device …

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  • Registration compared to the MDD – EU MDR

    2018-6-25 · The essentials of registration under new European Union Medical Device Regulation (EU MDR) are very similar to those under the current Medical Device Directive (MDD). Namely, those placing medical devices on the European market have to register, as do the Authorised Representatives of non-European …

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  • Materials for Medical Manufacturing

    2011-5-1 · Materials in medical vary widely by the application, notes Hanan Fishman, president, PartMarker Inc. (Fort Washington, PA), developer of PartMaker software. “Medical manufacturing is a very broad term, so the material various manufacturers use depends on the product being manufactured and its application,” Fishman …

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  • Corrective and Preventive Action for Medical

    2018-1-8 · Its basics are laid down in the standard ISO 13485 and also in the FDA regulations 21 CFR 820. The main objective is to identify and eliminate the causes of quality defects in medical devices. For that purpose, it is important to have all data available relevant to the quality of a medical device. CAPA procedures and why …

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  • Ultra-High-Molecular-Weight Polyethylene

    2013-8-10 · Previously, medical devices were selected based on its material and bulk properties. However, it is now recognized that the surface properties of the device mainly govern its biomedical applications. In most cases, a surface modification is considered to be a prerequisite for better biocompatibility.

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  • Tidda AI Zana earns medical device CE mark Europe

    Zana Technologies GmbH (Zana), a German-based digital health company, announces that it has received the Class I Medical Device CE Mark for its Artificial Intelligence-supported health monitoring platform Tidda AI.. The CE certification mark assures that Tidda AI, which is the flagship product of Zana Technologies, conforms to the stringent requirements of the Medical …

    Get Price
  • igus® energy chains, flexible cables, polymer

    igus® manufacture energy chains, flexible cables and harnessed cables, polymer bearings including bushings, ball joints, linear bearings and linear slides

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  • Medical Device Companies in Israel - Israel Exporter

    LifeCan Medical has developed a device that converts a standard manual BVM respirator into an automatic ventilator. The device was developed with a combination of engineers, doctors, quality and regulation personnel.

    Get Price
  • Guide on medical devices (MD/IVD) CE marking

    Both the Medical Devices Directive (93/42/EEC) and In Vitro Diagnostic Medical Device Directive (98/79/EC) require manufacturers or, their authorised representatives or others placing medical device(s) on the EEA market, to provide certain information to the Competent Authorities in the EEA Member State where …

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  • Medtech | UL

    2021-5-12 · Medical device testing solutions Our global reach and local presence allow us to deliver innovative, customized solutions to streamline testing and simplify the certification process. We can tailor the testing to your own specifications, as well as offer expert advice to help ensure the most efficient use of your time and budget.

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  • MDD | Medical Device Directive | Information ...

    MDD 93 42 EEC. Medical Device Regulation. Responsibilities of the Manufacturer, Authorized Representatiove, Competent Authority, Notified Body, the CE label.

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  • Nemaura Medical Announces Submission to

    2021-3-11 · Loughborough, England, March 11, 2021 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and ...

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  • Ultimax-i FPD Version | x-ray | Canon Medical

    Due to medical device regulatory reasons, not all products/service displayed on this Canon Medical Systems global webpage are available in all countries, regions or markets. Future availability of the products/service cannot also be guaranteed. Please contact your local Canon Medical Systems representative for further details.

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  • World Medical Device Contract Manufacturing

    2019-12-5 · PUNE, India, Dec. 5, 2019 /PRNewswire -- The report for 'Medical Device Contract Manufacturing Market' is Available at ReportsnReports.com with latest advancement. Report covered the detailed ...

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  • Corrective and Preventive Action for Medical

    2018-1-8 · Its basics are laid down in the standard ISO 13485 and also in the FDA regulations 21 CFR 820. The main objective is to identify and eliminate the causes of quality defects in medical devices. For that purpose, it is important to have all data available relevant to the quality of a medical device. CAPA procedures and why …

    Get Price