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Stage preparation

2 Companies

15 Products

MOTT MOBILE SYSTEM GMBH & CO. KG

Germany

Mott Mobile Systems is your specialist for mobile stages & facilities. For many years, the name Mott has stood for mobile platforms, stands and stages in the sports, events, concert and production industries. We also provide folding tables and chairs that are ideal for meetings, catering functions and all kinds of events. Our products, which are proudly made in Germany, are known for their high quality, their ease of use and their wide range of applications. Our product development incorporates the use of modern CAD workstations to realise our products in 3D. Decades of experience as a manufacturer of stages, along with the wide variety of individual customer requests we have carried out over that time, have allowed us to make continual improvements and optimisations to our product range. All of Mott's products are constantly scrutinised, with the functions carefully considered and refined as required.

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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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Stage preparation

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