Results for

Traceability

3 Companies

13 Products

OPTOLUTION MESSTECHNIK GMBH

Germany

The company OPTOLUTION MESSTECHNIK GMBH, is a Service Provider, which operates in the Optical measuring equipment industry. It also operates in the laseroptical flow measurement, and on-site-calibration flow sensor industries. It is based in Lörrach, Germany.

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On-site calibration of flow sensors

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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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KNORR & MACHO GMBH - TECHNISCHE GUMMIFORMTEILE

Germany

Rubber moulded parts that are set apart by flexibility, innovation and quality: In line with this principle, we have been manufacturing customised, technical rubber moulded parts for an international customer segment for over 25 years. A suitable contact partner will be on hand to attend to your enquiry and provide you with consultation and support. Our range of services and products includes: Efficient mould design, flexible implementation of the sample/batch mould and resource management; parts sampling and initial sample test reports through to final batch production; flexible and cost-efficient manufacturing of your order to the highest level of quality for small batches and/or mass production via our state-of-the-art fleet of machinery; high-quality final processing of moulded parts according to a variety of procedures; certified quality assurance (9001: 2008) and a comprehensive final inspection; just-in-time deliveries incl. batch traceability; elastomer special parts made from rubber, plastic, composites of rubber-plastic, rubber-metal, plastic-metal or even rubber-plastic-metal depending on customer requirements.

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3 Companies