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Hardware and software project planning - Germany

4 Companies

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IBS AUTOMATION GMBH

Germany

ibs Automation supplies innovative CNC control solutions for the mechanical engineering and processing industries. This involves ensuring that the centre point of the tool is always guided quickly and precisely. Thanks to more than 20 years' experience with CNC, ibs Automation is able to provide control solutions for manufacturing processes that prioritise path accuracy above all else. Achieving what is technically possible, pushing existing boundaries, providing customers with inspiring, excellent solutions – these are the goals that ibs Automation sets for their business. The key to achieving these goals is their combination of expert knowledge, detail-oriented approach and a drive to understand their customers' aims. Further to this, ibs Automation wants to offer their customers solutions that give them a real competitive advantage. ibs Automation solutions are currently in use in gantry systems, special machines and robotics, impressing customers in a range of sectors all around the world.

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ADKOM ELEKTRONIK GMBH

Germany

ADKOM ™ has been an expert industry partner for the planning, coordination and implementation of display projects since it was founded in 1992. The company's high quality standards are supported by its certification to DIN EN 9001: 2015, as well as ISO-certified suppliers. A qualified team of engineers and sales experts are available to answer any queries relating to display projects. Acting as an interface between European medium-sized businesses and selected partners in Asia, ADKOM specialises in custom displays and modules such as LCDs, TFTs, OLEDs and E-papers, as well as COG-Modules. Its range of products and services also extends to the development of electronics and products relating to displays. In response to the ever more complex requirements of the "digital age", ADKOM's experienced team of developers has come to focus on both hardware and software development of electronic control systems and microcontroller programs, such as ARM-based embedded systems.

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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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DALOG DIAGNOSESYSTEME GMBH

Germany

DALOG® GmbH was founded in 1998 in Augsburg and develops robust, reliable hardware and software for monitoring machines and processes. We are always open to new challenges. DALOG® provides customer-specific solutions in the area of machine monitoring and machine diagnostics, and takes on measurement jobs, including project planning, application and evaluation. This has helped us to gather experience in a wide range of operations and applications.

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Hardware and software project planning - Germany

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4 Companies