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Project management assistance

GermanyStuttgart, Freiburg and Baden-Wurtemberg
2 Companies 3 Products

  1. KÖSTLIN PREPRESS SERVICES GMBH & CO. KG

    Germany

    With Köstlin Prepress Services, you can professionally implement all steps of the pre-press process for each individual packaging component and for each printing process. To do this, we appoint a central contact in-house for each project who coordinates all the work. With us as your single interface, you have an efficient partner who will assist you in the creation phase of your packaging design, ensure the specific reproduction of any type of packaging, coordinate with your manufacturers and provide one of the most modern production facilities for flexographic printing clichés and sleeves available. Unnecessary overlaps in this phase are avoided, efficiency is increased and costs are reduced. In addition, we provide you with our tailor-made database solution that maps your individual "packaging workflow" with release management and acts as a collection point for your final print data.

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  2. 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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