Results for

Technical regulations

3 Companies

24 Products

SCHÜTZ GMBH MESSTECHNIK

Germany

Schütz Messtechnik is an experienced and qualified company that has been operating as a service provider and an equipment manufacturer for energy companies since 1968. In the amenities industry, Schütz checks the public gas pipeline networks in accordance with the regulations G 465, G 466/I and G 466/II of the German association for gas and water (DVGW), carries out leak and pipeline detection and exchanges meters. In addition, it holds technical seminars and training sessions for employees from utility companies. Schütz GmbH has been certified by the DVGW as a company specialising in checking gas pipelines. Energy companies using a geographic information system (GIS) can check their pipeline network with Schütz's digital technology. Among Schütz GmbH's client base today are more than 100 municipal utility companies, with whom the company maintains long-standing, close and trusting business relations.

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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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ZENTRO ELEKTRIK GMBH KG

Germany

Zentro-Elektrik is shaping the future – and has been for more than 60 years. Whenever we need to respond flexibly to changing requirements and framework conditions, our creative, professionally qualified staff ensure that our products are always innovative and impress even our most demanding customers with their technical expertise. As the leading German power electronics company on the market, alongside our partners, our product quality enables us to stand out and serves as a symbol of our experience and reliability. As a result, we not only feel the need to uphold our traditions, but we also have a wealth of experience and innovative strength built up over many years which cannot be replicated. Thanks to our high-quality philosophy, Zentro-Elektrik has become a synonym for reliability in the electronically regulated electricity distribution market. Since our company was founded in 1956, our facility in Pforzheim, Germany, has been the heart of our work.

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Technical regulations

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