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Technical assessment - Germany

Germany
6 Companies 5 Products

  1. TECHNISCHE DOKUMENTATION - KARLA FLEMMING

    Germany

    Erstellung von gesetzeskonformen verständlichen Betriebsanleitungen für Maschinen, Maschinenteile und Konsumgüter zur Erlangung der CE-Konformität. Technische Dokumentation - Karla Flemming | Ingenieurbüro - Technische Redaktion, ist Ihr starker Partner wenn es darum geht Bedienungsanleitungen, Instandsetzungsanleitungen, Wartungsanleitungen, Softwareanleitungen, Kurzanleitungen, Firmenbroschüren, Ersatzteilkataloge, Produktdatenblätter, Sicherheitsdatenblätter, Betriebsanweisungen u.a., unter Beachtung der Risikobeurteilung zu erstellen. Dann sollte das Ausstellen der Konformitätserklärung für Ihre Maschine oder Produkt kein Problem mehr sein. Wenn Sie technische Anleitungen benötigen, kontaktieren Sie mich bitte. Sehr gerne erstelle ich Ihnen eine Angebot nach Rücksprache üben den Auftragsumfang. Als Zertifizierte Technische Redakteurin und Dipl.-Ing. (FH) Maschinenbau und jahrelanger Erfahrung in den Bereichen Dokumentation und Technik, bin ich ein adäquater Partner in Sachen Technischer Dokumentation.

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  2. AUGUST MÖSSNER GMBH + CO KG

    Germany

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    We solve our customers' sawing, cutting and testing problems using automated specialised machinery. The integration of band saws and robots takes centre stage in our work. In addition to our products, we also offer an extensive range of services relating to development, commissioning, operational support and assessments. We systematically implement the wishes and requirements of our customers in machinery and installations with unbeatable efficiency. Our areas of business are casting technology, machining aluminium, machining abrasive materials and, our specialist field, dismantling nuclear facilities. In addition, we are always ready and in a position to break new ground for our customers and make new projects a reality. Thanks to our impressive technical skills in manufacturing bespoke products and solutions, we are a flexible, fast and down-to-earth service provider.

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  3. KUGEL- UND ROLLENLAGERWERK LEIPZIG GMBH

    Germany

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    We manufacture over 900 types of roller bearings every year. This ranges from standard roller bearings to customised special bearing solutions over a range of diameters from 50 mm to 1500 mm. In addition to various roller bearing components, we also supply our customers with special precision components and roller bearing accessories. Our particular strength lies in research and development work for application-optimised special bearings. Working directly with customers, we fine-tune, test and implement technical options. Our engineering portfolio not only includes project-based calculations, but also practical durability and strength tests, as well as bearing assessments. We offer quality through expertise – maximum quality is the common thread through our entire manufacturing – from procuring materials to delivering products. KRW Wälzlager has been producing bearings from the historical site to the west of Leipzig, eastern Germany, since 1934. We also have sales offices in China, India, Kazakhstan and Southeast Asia in order to be in close proximity to customers and to offer application-specific support.

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  4. MAXCERT LTD

    Germany

    Maxcert can provide the strategic and technical guidance to develop an appropriate project plan, as well as assist with the implementation of any stage of the MDR certification process. QMS / Risk Management - Strategy for Regulatory Compliance - MDR-Specific QMS Changes - Classification & Conformity Assessment - Other EU MDR Directives & Regulations - Risk Management Evaluation Criteria - Benefit Risk Analysis - MDR Readiness Audits Clinical Evidence - Guidance on New Clinical Evidence Requirements - Legacy Product Data Review - Performance Evaluation Plan / Report (PEP/PER) - Analytical Performance Report - Clinical Performance Plan / Report - Clinical Performance Study Plan (CPSP) - Scientific Validity Report Labelling & UDI - Intended Purpose / Claim Review - Labels & Instructions for Use Requirements - Applicable Standards - UDI Requirements & Symbols Technical Documentation - Technical Documentation Review & Preparation - GSPR Gap Assessments & Traceability Matrices - Test, Hardware, Software Requirements Post-Market Surveillance / Vigilance - Post-Market Surveillance Plan / Report - Post-Market Follow-up (PMPF) Plan / Report - Incident Reporting - Periodic Safety Update Report (PSUR) Economic Operators / EUDAMED - Person Responsible for Regulatory Compliance (PRRC) - Registration of EO’s & Devices - Control of Suppliers (Process/Method) To speak to an MDR expert, or if you don’t see the services you are looking for, contact us

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  5. ESIS GMBH

    Germany

    ESIS GmbH have long experience in rendering service in technical areas, NPP commissioning and operation, quality assurance, conformity assessment, safety analyze, design, licensing and also in the field of NPP Personnel Training. They were participants of international projects on NPP safety enhancement and creation of NNEGC Energoatom normative documentation, NNEGC Energoatom Personnel Training System creation and upgrading, creation of Product Conformity Assessment System of Energoatom, etc. The most part of specialists of ESIS GmbH have long experience in NPP operation (former Ukrainian NPPs employers). ESIS key experts earlier worked in NNEGC Energoatom, Ukrainian NPP Personnel Training and Licensing Department. They are the authors and participants of development of all standards of Energoatom and the Ministry of Fuel and Energy in the sphere of NPP personnel training.

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  1. PERO AG

    Germany

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