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Surveillance products - Germany

2 Companies

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BKM PRÄZISIONSWERKZEUGE STANZ UND BIEGETEILE GMBH

Germany

We are specialists in sizing and manufacturing stamped and punched parts which are suitable for manufacturing, including designing and constructing the tools required for this purpose. Our range of processing services includes copper/copper alloys, brass, steel/stainless steel and aluminium. Our specialists can translate your design requirements into reality at our four workshops which have over 50 punching machines, six punching units and additional equipment for threads, assembling and laser welding which can be integrated, as well as devices for vibratory grinding, polishing and tempering. BKM's manufacturing depth is extremely high, meaning that we can always undertake the core processes for tool and part manufacturing ourselves. Small and medium series production are part of our key areas of expertise thanks to our BIHLER BNC manufacturing systems in the field of punching. We manufacture large series on punching machines, typically with camera surveillance and 24/7 operation with automatic container changers, if required.

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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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Surveillance products - Germany

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