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Clinical studies

GermanyStuttgart, Freiburg and Baden-Wurtemberg
2 Companies 68 Products

  1. METRAX GMBH

    Germany

    As an innovative medical technology company, METRAX has advanced its position worldwide to become a pioneer in the field of emergency medicine. Since 1973, we have been combining our outstanding expertise with intelligent medical technologies and the latest clinical studies to support the development, production and distribution of our tried and tested professional and automatic defibrillators from the PRIMEDIC brand. A spirit of pragmatic innovation and many years of experience is the lifeblood pumped into our daily research and development work. PRIMEDIC. Saves Life. Everywhere. High quality products made in Germany: For emergency rescue personnel across the globe, PRIMEDIC defibrillators stand for the highest safety standards, swift readiness for use and exceptionally easy operation – all at an excellent price/performance ratio. Our products are distinguished throughout their entire lifecycles by an uncompromising approach to quality and unrestricted functional capability, even under the toughest operating conditions.

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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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