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Import-export - medical and surgical equipment - Service Provider - Germany

GermanyService Provider
  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

  2. METECON GMBH

    Germany

    The company METECON GMBH, is a Service Provider, which operates in the Import-export - medical and surgical equipment industry. It is based in Mannheim, Germany.

  3. KBV GESELLSCHAFT FÜR KRANKENHAUS-BERATUNG UND -VERSORGUNG MBH & CO. KOMMANDITGESELLSCHAFT

    Germany

    The company KBV GESELLSCHAFT FÜR KRANKENHAUS-BERATUNG UND -VERSORGUNG MBH & CO. KOMMANDITGESELLSCHAFT, is a Service Provider, which operates in the Import-export - precision instruments industry. It also operates in the Import-export - medical and surgical equipment, and Import-export - medical and surgical equipment industries. It is based in Leipzig, Germany.

  4. AESKU. DIAGNOSTICS GMBH

    Germany

    The company AESKU. DIAGNOSTICS GMBH, is a Service Provider, which operates in the Import-export - precision instruments industry. It also operates in the Import-export - medical and surgical equipment, and Import-export - medical and surgical equipment industries. It is based in Wendelsheim, Germany.

  5. HOLZNER MEDIZINTECHNIK GMBH

    Germany

    The company HOLZNER MEDIZINTECHNIK GMBH, is a Service Provider, which operates in the Import-export - precision instruments industry. It also operates in the Import-export - medical and surgical equipment, and Import-export - medical and surgical equipment industries. It is based in Nußloch, Germany.

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  1. IMF MARKETING GMBH

    Germany

    The company IMF MARKETING GMBH, is a Service Provider, which operates in the Import-export - precision instruments industry. It also operates in the Import-export - medical and surgical equipment, and Import-export - medical and surgical equipment industries. It is based in Gera, Germany.

  2. KEN SOOPER VERTRIEBS- GMBH

    Germany

  3. NING SHING MEDICAL GMBH

    Germany

  4. W & H DEUTSCHLAND GMBH

    Germany

  5. IPS INTERMEDICAL PROMOTION SERVICE GMBH

    Germany