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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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TIS INDUSTRIESERVICE

Germany

With over 20 years' experience we make a significant contribution to the business success of our industrial customers. Almost all fields of industry rely on our performance and profit from our customised service – in terms of quality and flexibility, as well as costs. Thanks to our expertise, we are also able to produce large orders in an agreed time-frame (e.g. complete plant relocation to Turkey over a 5-month period). Excellent international contacts also ensure that your operations are run smoothly and processed in line with legal requirements. Machine assembly/plant assembly, shelf testing in accordance with DIN EN 15635; Specialist in the testing of pallet racking, disassembly/re-assembly, machine relocation/production relocation, assembly/disassembly of KBK crane installations, planning/project management, maintenance/repair, industrial cleaning, building cleaning, facility management (specialist in accordance with WHG)

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