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Technical assistance with software

4 Companies

4 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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ACCURATE TECHNOLOGIES GMBH & CO. KG

Germany

The company ACCURATE TECHNOLOGIES GMBH & CO. KG, is a Manufacturer/ Producer, which operates in the Software, technical and scientific industry. It also operates in the Software consultants, CAD/CAM Computer Assisted Design/Computer Assisted Manufacturing - software, Software consultants, and CAD/CAM Computer Assisted Design/Computer Assisted Manufacturing - software industries. It is based in Stuttgart, Germany.
APEX TOOL GROUP GMBH

Germany

Apex Power Tools is part of the Apex Tool Group and represents one of the most diverse families of products in the manufacturing industry, comprising global brands such as Apex, Cleco, Dotco, and Recoules-Quackenbush. Our products serve several different markets, including aerospace, automotive, energy, and other product assembly industries. From fastening and material removal tools to sophisticated drilling equipment, our products are used in quality- and safety-critical applications around the world. Based in Lexington, South Carolina, and with Headquarters for EMEA in Westhausen, Germany, Apex Power Tools operates a worldwide network of manufacturing and sales/service facilities, employing more than 1, 500 staff members in the Americas, Europe, and Asia Pacific. We are adept at meeting the technical challenges faced by today’s manufacturers, and we specialize in products that deliver value through superior functionality, ergonomics, and long-term performance.

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Software Solutions

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DR. WESTERNACHER & PARTNER GMBH

Germany

The company DR. WESTERNACHER & PARTNER GMBH, is a Service Provider, which operates in the Software creation and development industry. It also operates in the CAD/CAM Computer Assisted Design/Computer Assisted Manufacturing - software, Software, Onboard electronic systems, CAD/CAM Computer Assisted Design/Computer Assisted Manufacturing - software, Software, Onboard electronic systems, and metrology industries. It is based in Reutlingen, Germany.

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Technical assistance with software

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4 Companies