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Technical assistance with software - Service Provider - Germany

GermanyService Provider
4 Companies 4 Products

  1. 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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  2. BERATUNGSGESELLSCHAFT DIENSTLEISTENDER UNTERNEHMEN MBH (BDL)

    Germany

  3. DR. WESTERNACHER & PARTNER GMBH

    Germany

    The company DR. WESTERNACHER & PARTNER GMBH, is a Service Provider, which operates in the Software creation and development industry. It also operates in the CAD/CAM Computer Assisted Design/Computer Assisted Manufacturing - software, Software, Onboard electronic systems, CAD/CAM Computer Assisted Design/Computer Assisted Manufacturing - software, Software, Onboard electronic systems, and metrology industries. It is based in Reutlingen, Germany.

  4. LTB400 AVIATION SOFTWARE GMBH

    Germany

    The company LTB400 AVIATION SOFTWARE GMBH, is a Service Provider, which operates in the CAD/CAM Computer Assisted Design/Computer Assisted Manufacturing - software industry. It also operates in the Desktop publishing, DTP - software, Computer-assisted planning - software, Desktop publishing, DTP - software, and Computer-assisted planning - software industries. It is based in Hallbergmoos, Germany.

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Technical assistance with software - Service Provider - Germany

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