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Management control and planning

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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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GERWECK GMBH OBERFLÄCHENTECHNIK

Germany

Gerweck GmbH surface treatment is one of the leading service companies for galvanic surface processing and the plating of metals and light metals. The successful combination of band and single part galvanization in conjunction with high-quality and customer satisfaction has earned us customers from the automotive, electronics and medical technology industries. We work with customers from the early stages of new projects using our newest technologies to create prototypes, all the way through to series production. In order to be able to meet the requirements of dynamic markets, technological plant development and the newest methods of analysis remain at the forefront of what we do. We offer collaboration and a flexible adaptation of our systems to your products. Our production planning is managed using modern system control as well as an ERP system supported by SAP. For our company this is the first important step within the framework of digitalisation 4.0.

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Management control and planning

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