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Technical assessment

GermanyStuttgart, Freiburg and Baden-Wurtemberg
2 Companies 4 Products

  1. 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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  2. 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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