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Medical devices

3 Companies

440 Products

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MAXMED MEDICAL

Germany

Maxcert’s team has expert knowledge to help you navigate through the complex regulatory challenges that the new EU MDR bring. We can assist you through out the entire process to ensure that you and your business are compliant with all of the EU MDR requirements. Our experienced team acts as consultants for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For more information, reach out to us at or contact us online Maxcert Team
RUDOLF GUTBROD GMBH

Germany

Rudolf Gutbrod GmbH in Dettingen an der Erms, Swabia is constantly setting new standards in innovative coating technology. The company is a European leader in fluoropolymer processing. Founded in 1964, it is one of Germany's pioneers in fluoropolymer surface technology and, as a licensee of well-known raw materials manufacturers, is among the first companies in Europe to be contacted regarding functional layers with non-stick properties, low friction, chemical resistance and corrosion protection. The company's continuous efforts in development ensure state-of-the-art processes. It coats raw materials around the world. It is engaged in constant knowledge sharing on an international level to guarantee the highest quality in future solutions that will satisfy a wide range of customer requirements.

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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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