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Documentation- technical

2 Companies

143 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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BRÄNDLE PRÄZISIONSTEILE GMBH

Germany

For over 50 years, Brändle Präzisionsteile GmbH has been setting new standards in the field of machining manufacturing technologies. Founded by Werner Brändle in 1959 in the Berkheim district of Esslingen, this traditional Swabian company has been distinguished by high-quality solutions in the areas of honing and deep-hole boring of individual parts, small batches and prototypes from its very beginnings. At Brändle Präzisionsteile GmbH, long-standing experience, quality, reliability and technical insight go hand in hand. These high standards are fulfilled every day: All manufacturing processes are documented by employees with maximum precision and managed via a transparent planning process, which includes work schedules, measuring equipment and test specifications. Quality assurance is carried out on the basis of customer agreements, for which a 100% dimensional inspection and spot checks are guaranteed for the surface produced.

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