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Planning and implementation application - Service Provider - Germany

3 Companies

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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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P + L HOFFBAUER & CO. GMBH

Germany

With the expertise of the external planner and consultant, we have been developing strategy-compliant system and process solutions for intralogistics as well as the entire supply chain for more than 25 years, and we have successfully implemented them – vendor-neutral and absolutely customer- oriented. With P+L by your side, you shorten delivery times, lower logistics costs and increase your flexibility. In this way, you align your company for the future and benefit from a high level of investment security.

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TH DATA GMBH

Germany

The company TH DATA GMBH, is a Service Provider, which operates in the Software for industry industry. It also operates in the production planning, and applications for production planning industries. It is based in Berlin, Germany.

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Planning and implementation application - Service Provider - Germany

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3 Companies