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Hardware and software project planning

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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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Hardware and software project planning

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