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Technical assistance - Service Provider - Germany

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3 Companies 27 Products

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  1. EXCELENCIA GMBH

    Germany

    The company EXCELENCIA GMBH, is a Service Provider, which operates in the Information systems - advice industry. It also operates in the Programming and software, Integrated Management Software (IMS), ERP - integrated management software, Programming and software, and Java technical assistance industries. It is based in Erkelenz, Germany.

  2. STEFFEN TANZMANN

    Germany

    The company STEFFEN TANZMANN, is a Service Provider, which operates in the IT Services industry. It also operates in the PHP technical assistance industries. It is based in Radeberg, Germany.

  3. 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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