Results for

Documentation- technical

6 Companies

143 Products

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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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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DE-PACK GMBH & CO. KG

Germany

Innovative packaging and customer-specific developments: KLT containers, plastic containers, foam packaging, EPS and EPP packaging, deep-draw packaging, twin-wall plastic packaging, ESD/VC We primarily focus on the satisfaction of our customers. We develop innovative solutions and pack your products with volume optimisation, cost-effectively and so that they are secure for transportation – and all with a positive image. We are happy to advise you on packaging for your products: - Foam packaging, small load carriers (KLT) - Plastic packaging - Retention packaging - Corrugated, solid board and wooden packaging - Special types of ESD/VCI packaging Our services - Packaging development with prototypes and technical documentation in 2D and 3D - Drop test in accordance with DIN 22248 with documentation - Commissioned packaging - Storage with just-in-time deliveries
A. BOLZ APPARATEBAU GMBH

Germany

Stainless steel vessel manufacturing – quality and innovation from the Allgäu region! The Bolz-EDEL Group designs and manufactures stainless steel vessels of the finest quality. We are your go-to partner for carefully considered solutions in the field of process vessels and storage tanks. Thanks to our innovative 3D construction designs, cutting-edge production technologies, quality management incorporating seamless vessel documentation and trained specialists, quality and reliability are guaranteed. Your technical processing requirements are painstakingly implemented by industry specialist engineers. Every size and quality is possible – from ten-litre volume pharmaceutical batch vessel to cylindro-conical fermentation tanks for breweries and even large tanks with a capacity of two million litres constructed on site. The internationally recognised brands of Bolz Apparatebau and EDEL Tank have been producing quality innovations from the Allgäu for many decades!

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BRÄNDLE PRÄZISIONSTEILE GMBH

Germany

For over 50 years, Brändle Präzisionsteile GmbH has been setting new standards in the field of machining manufacturing technologies. Founded by Werner Brändle in 1959 in the Berkheim district of Esslingen, this traditional Swabian company has been distinguished by high-quality solutions in the areas of honing and deep-hole boring of individual parts, small batches and prototypes from its very beginnings. At Brändle Präzisionsteile GmbH, long-standing experience, quality, reliability and technical insight go hand in hand. These high standards are fulfilled every day: All manufacturing processes are documented by employees with maximum precision and managed via a transparent planning process, which includes work schedules, measuring equipment and test specifications. Quality assurance is carried out on the basis of customer agreements, for which a 100% dimensional inspection and spot checks are guaranteed for the surface produced.

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NKL GMBH

Germany

As one of Germany's largest manufacturers of toroidal chokes for electronics, we have a reputation as an expert point of contact for EMC and inductive components. The satisfaction of our customers is our main priority that we fulfil through expert advice, continuous further development of our quality management system, punctual delivery and competitive prices. Wolpertshausen is home to development, prototyping, small series production, the EMC measurement laboratory and final inspection, while we produce large quantities at our partner companies abroad. The technical expertise of our staff in the field of EMC and inductive components is impressively documented by seminars and lectures at universities, regular publications of specialist articles in electronics journals and collaboration in VDE committees on standardisation work. ISO 9001: 2008 certification

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Documentation- technical

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6 Companies