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Software - standard

GermanyStuttgart, Freiburg and Baden-WurtembergService Provider
2 Companies 37 Products

  1. EP EHRLER PRÜFTECHNIK ENGINEERING GMBH

    Germany

    EP Engineering GmbH supplies a complete range of products and services in the metrology and testing technology field, specialising in high-precision flow measurement technology. As a complete service provider, we offer customers the highest quality, supplying test benches, measuring systems, software solutions and calibration and service. We are one of the few companies in Germany to own and operate a DAkkS (German Accreditation Body) laboratory. In order to further develop current standards and measuring methods, we conduct research with our partners to identify new paths in metrology and testing engineering for gases and liquids, and maintain close cooperation with the Physikalisch-Technische Bundesanstalt (PTB) (national metrology institute) in Braunschweig.

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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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