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Software implementation

2 Companies

9 Products

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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ASAMBY CONSULTING GMBH

Germany

Scaling from within – Long-term commercial success comes from within! We combine consultation on the subjects of operational excellence and organisational behaviour so that your company has the right employees and the right tools to develop and implement effective processes. We help your organisation to concentrate on those things that are essential for you to achieve your strategic goals. Tools for implementing strategies such as road maps and objectives and key results (OKR) give your company the clarity you need to be successful. Cloud automation is here to stay. Digital transformation is imperative. We help you select the right software tools. We identify the right automation processes and find the right solutions for you – as specific as necessary, as affordable as possible. We work completely remotely, as do many of our customers.

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2 Companies