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Compliance management services

2 Companies

5 Products

FLUID SYSTEMS & AUTOMATION GMBH

Germany

Fluid Systems & Automation GmbH (FSA Valve) is a leading company in the field of fluid technology. It develops, produces and sells valves and automation solutions for industrial applications worldwide. FSA Valve places great value on innovation, quality and sustainability. Product range: Solenoid valves: available in brass, stainless steel and plastic, suitable for water, air, oil and aggressive chemicals, in normally open and closes variants Motorised ball valves: made from brass and stainless steel, ideal for irrigation, mechanical engineering and the food industry, with precise control options Ball valves: one-, two- and three-part variants for efficient flow control, robust and reliable. Pressure controllers: pressure reducing controllers, pre-pressure controllers and reducing stations for constant pressure control (FSA Valve). Pneumatic actuators: double acting and spring return actuators for efficient pneumatic systems. Quality and sustainability: FSA Valve focusses on quality and environmental management to ensure the best possible product quality and environmentally-friendly production. This involves internal quality controls and compliance with international standards. . Customer support and service: the company offers comprehensive customer support with regard to production selection, installation and maintenance as well as technical documentation and maintenance kits for all products.

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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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Compliance management services

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2 Companies