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Change management

3 Companies

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SI2 PARTNERS

Germany

Si2 Partners is a boutique consultancy and management services firm. We help our clients leverage services to beat the competition and win in industrial markets. We work across many industries and types of companies from all over the world. We provide consulting solutions and business execution support. Through our “On-Demand” service we offer access to expert practitioners and consultants for practical management advice, insights and best practices to help managers solve problems and get things done -as and when required. We offer a unique blend of management and consulting experience and deep smart expertise in our areas of practice and the industries we serve. Our offerings include end-to-end consulting solutions, business execution services as well as unbundled, on demand management and expert support. We provide best practice insights, research and benchmarking, strategic analysis and solution development, rapid implementation improvement programs as well as organizational and operational transformation. For underperforming companies, business units or projects we offer interim management, troubleshooting, turn-around or recovery programs with focus on rapid problem resolution and emphasis on liquidity and cashflow. We also work with companies to enhance their management and business development capabilities as they seek to expand and improve their business, often in new markets.
MARVIN LUDWIG - UNTERNEHMENSBERATER FÜR PROZESSMANAGEMENT UND CHANGE-MANAGEMENT

Germany

The company MARVIN LUDWIG - UNTERNEHMENSBERATER FÜR PROZESSMANAGEMENT UND CHANGE-MANAGEMENT, is a Service Provider, which operates in the Electronic data processing - software industry. It also operates in the Business information, Company ratings, Management advice, Communication, Business information, Company ratings, Management advice, and Communication industries. It is based in Stuttgart, Germany.
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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