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Technical audit - Service Provider - Germany

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2 Companies 4 Products

  1. BDP MECHANICAL COMPONENTS DEUTSCHLAND GMBH

    Germany

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    The bdp Group, founded in 1992 and comprising 150 employees, is based in Berlin with over 14 further offices in Bulgaria, China, Germany, Poland, Spain and Switzerland. The subsidiary bdp Mechanical Components, which has existed since 1982, is a specialist supplier in the international sourcing of casting, forging, machining and automotive parts for European manufacturing companies from China and Eastern Europe. We supply over 50 European customers in the automotive, mechanical engineering, rail, energy, gas and liquid transport sectors. Everything from a single source: Model making, initial sampling, parallel production (start-up), series production, optimisation. Product quality. Strategic acquisition: Optimisation of acquisition processes, reduction of acquisition costs. Selection of suitable suppliers, supplier audits: Evaluation of technical production and quality capabilities. Quality control on site: Monitoring production, outgoing goods inspection before shipping

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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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