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Technical audit - Germany

5 Companies

4 Products

BDP MECHANICAL COMPONENTS DEUTSCHLAND GMBH

Germany

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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SPANDAUER VELOURS GMBH & CO. KG

Germany

Spandauer Velours GmbH & Co. KG, a leading manufacturer of velour and plush fabric, has been a successful market player for over 30 years. The company's focus is on high-grade velour and plush fabrics for the paint roller and cleaning industry as well as for commercial interiors. Our more than 200 customers worldwide include well-known paint roller manufacturers and cleaning companies, leading textile houses and commercial interior outfitters as well as many small and medium-sized companies. We meet your requirements and expectations through strong cooperation based on trust. Responsible, fair and open cooperation with our customers, employees and suppliers forms a solid basis for our activities. Regular audits, an annual certification according to DIN EN ISO 9001 and our company suggestion scheme ensure that we continuously improve our processes.

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Interior Textile Fabrics

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TER CHEMICALS DISTRIBUTION GROUP

Germany

The TER Chemicals Distribution Group is a globally active distributor of special chemicals and food additives with branches in 16 countries. Products offered range from additives, waxes, resins and plastics of all kinds, through pigments and special chemicals right up to additives for the food and animal feed industry. As a committed technical and chemical consultant in Europe, our mission is to generate added value with our qualified specialists, quality products and outstanding service. It is our vision to be the first-choice distributor for our customers and suppliers. For us, the satisfaction of our customers and suppliers is the standard for our definition of quality. Trust is good, monitoring is better. Compliance with quality assurance measures is ensured through regular checks and audits: ISO 9001, ISO 22716, AEO F, Ecovadis, FAMI-QS, HACCP, Responsible Care, BIO certificate

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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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MDR Technical Documentation

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LLOYD'S REGISTER DEUTSCHLAND GMBH

Germany

Lloyd's Register was founded in 1760 as a maritime classification society. Nowadays we are one of the world's leading technical service providers, offering our customers in over 75 countries solutions to make critical infrastructure more secure and efficient. Our income flows into Lloyd's Register Foundation, a charity that promotes scientific and technical research, education and public engagement in our field of activity. This way, we can concentrate on what drives us every day: Creating a safe world together. We only use auditors who have extensive knowledge of the industry. We place particular importance on taking your company's entire process chain into consideration during audits. Our top priority is increasing your company's performance in the long term.

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Technical audit - Germany

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5 Companies