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Device testing - Import export

Service Provider

United Kingdom

Medical device testing is tightly regulated due to the potential severity of an EMC or Safety failure. The term 'medical device' covers a wide range of items and we have extensive experience in testing in this area, covering items such as prosthetic limbs, hospital beds, patient monitors, TENS machines, blood pressure monitors, to name just a few. We are UKAS accredited to test for the Medical standards IEC/EN 60601-1 and IEC/EN 60601-1-2, covering the basic safety and essential performance of medical electrical equipment. We are also UKAS accredited for the following specific medical standards: -IEC 60601-1-11 Particular requirements for medical electrical equipment and medical electrical systems in the home healthcare environment -IEC 60601-2-10 Particular requirements for the safety of nerve and muscle stimulators Using a UKAS accredited laboratory gives manufacturers assurance accuracy, reliability and consistency.

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Switzerland

Medical Device Services / Medical Device Laboratory Testing INVITRO-CONNECT GmbH offers you: - General regulatory advice for medical devices - All regulatory examinations and tests under GLP - Project management and study monitoring - Medical Device Regulatory Service - Product testing for contained SVHC substances INVITRO-CONNECT offers you a complete service for the approval of medical devices according (EU) 2017/745 (Medical Device Regulation - MDR) / ISO 10993. From the development of an ideal test strategy to laboratory and project coordination, study monitoring, toxicological expertise and GLP inspections in the cooperation laboratories. We deliver the finalized test reports including the registration dossier - digitally and on paper, worldwide. Benefit from our diverse know-how, our experienced cooperation partners and an international, very well-organized network. Questions? -> contact@invitro-connect.com

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Switzerland

Microbiological examinations / Microbiological tests against viruses, bacteriophages, bacteria, yeast, molds, mycobacteria and bacterial spores for disinfectants, medical devices, pharmaceutical products and cosmetics Our team of experts supports manufacturers of biocidal and medical products as well as cosmetics and pharmaceuticals scientifically in the context of approval projects. For example, we create safety assessments for cosmetics and biocompatibility assessments for medical devices. Here we focus in particular on infection prevention and wound treatment products. For more information please contact INVITRO-CONNECT GmbH for assistance in developing specialized protocols for your test materials. INVITRO-CONNECT GmbH: Fast Project Execution: personal - competent - reliable --> contact@invitro-connect.com

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Italy

The basic equipment consists of an ultrasound generator, which is placed in the hold, and a receiver unit fitted with a microphone to receive the emitted ultrasound signals. It is a non-destructive method, non -invasive, can be used in all weather conditions, and can be used with cargo inside the hold.

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Russia

Designed specifically for servicemen of telecommunications companies. The product consists of four compartments: In the first large compartment there are compartments in which the following items can be placed: laptop, charger, folder, with documents, cables. In the second middle compartment there is a pouch with tools. In the pouch, you can place: connector crimping tool, flat, cross-head screwdrivers, stationery knife, wire cutters, a hammer, pliers, electrical tape/zip ties, RG45 connectors, Scotchloks. In the third middle compartment there is a pouch with compartments for items: measuring device, organizer with consumables, test tube, Tone Generator, Multimeter. The fourth small compartment can include: splitters, RJ45/RJ11 sockets, stock of Scotchlocks, stock of clamps, The backpack is designed specifically for servicemen of telecommunications companies.

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Ukraine

If you want to make a competitive product, quality must be undoubtedly considered as a top priority. It’s what should always be in focus during the whole project development lifecycle. Blackthorn vision offers a wide range of software testing and QA services that meet the highest industry standards, including security. Using our vast QA expertise and team flexibility, our QA engineers can improve the quality of your product while reducing time-to-market, management risks, and operating costs. Around the globe, companies lose trillions of dollars annually from software failure, which also involves reputational risks. We follow the best QA practices to ensure your product is bug-free: test each feature separately with clear objectives in mind, use the advanced bug tracking and reporting tools, apply a comprehensive range of scenarios for different devices, OS, etc., use regression tests, and many other customized techniques for the desired result.

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Belgium

Static Electricity is a major problem that has seriois impact on product quality, throughput and worker safety in many industries. In electronics and media, ESD Electrostatic Discharge affects semiconductor manufacturing, electronics assembly, flat panel display & hard disk drive production, and film processing. In industrial, food, telecom, textile, packaging, chemical, medical and pharmaceutical manufacturing, static electricity creates problems with cling and particulates such as in the processing of paper, fabrics, plastics, powders and other materials.

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Russia

Sensitiv imago® 530 is the previous model in the SensitivE line. Hi-tech hardware-software complexes for diagnostic scan, analysis and healing of organism. Senstiv imago 530 device is being assembled according to the new European quality management standards 9001 full accepted in EU in 2013. The device passed the medical laboratory testing class 2, according to the European Directive.

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Germany

Breath bags for the H.p. test with older 13C breath test devices. Twin breath bag

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Germany

Breath bags for older 13C breath test devices. One way breath bag 0.3l

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Germany

Desinfection wipes without alcohol, suitable for all alle FAN H 2 breath test devices. Enable you to clean and disinfect the device shell without polluting the sensor.

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Germany

10 litres calibration gas (100 ppm H 2 in nitrogen) for all FAN H 2 breath test devices. Compressed in an 1–litre aluminium can, at least 12 calibrations can be readily achieved.

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Germany

CE-marked one–way mouthpiece with bacteria and virus filter, suitable for all FAN H 2 breath test devices. Recommended mouthpiece that withholds micro organisms that maybe exhaled or inhaled during the test as far as possible, and thus significantly protects patients, staff and instrument inside from contamination.

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Germany

The 13C–breath test device HeliFAN plus is a compact and very reasonable 13C-infrared analyzer with a high sample throughput. It is especially designed for performing the Helicobacter pylory breath test at the clinics and at gastroenterologists. Together with this device you obtain the capable and easy to operate FANci–software, including more than 20 additional breath tests. Due to the availability of the common USB interface you can connect HeliFAN plus to your PC or laptop without any problems.

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