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Planning and implementation application

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DIENER ELECTRONIC GMBH & CO. KG

Germany

With 30 years of experience, Diener electronic‘s Plasma Surface Technology competence team as well as our cooperation partners in automation and implementation will show you individual ways to set up your planned production plant in a future-proof manner. As a global market leader, we have already sold more than 11, 000 systems worldwide. We offer the tailor-made solution for efficient processes in the fields of low- and atmospheric-pressure plasma systems as well as for parylene and vacuum systems. Let yourself be inspired by the possibilities we offer with our technologies and our unrivalled processes. We are looking forward to hearing from you! Comprehensive competence from one source Our customers benefit from the experience and know-how of dedicated employees as well as from state-of-the-art production equipment. Achieving success with advanced solutions At several locations in Baden-Württemberg, we develop and produce innovative solutions for economic, precise and environmentally friendly plasma treatment of surfaces – and we do this with enormous success. Since the company was founded, we have grown continuously and are now one of the leading manufacturers of plasma systems worldwide. Applications of our systems: Ultra-fine cleaning Surface activation, coating, etching Hydrophilic/hydrophobic coating Degassing / outgassing Height simulation Sensor calibration Leak test

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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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