Results for

Regulatory compliance - Germany

5 Companies

17 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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Person Responsible for Regulatory Compliance (PRRC)

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ABRASCH GMBH

Germany

We are a specialist in supplying high-quality made-to-measure brass parts for the automotive industry. We are an innovative solution provider that serves its customers by products and services in the automotive sector: offered products: a wide range of OEM quality-to-price auto spare parts including synchronizer rings, brake system connectors, hydraulic and pneumatic system fittings, battery terminal connectors, and other parts. Our supplied products can be tailored according to customer requirements in terms of made-to-measure design and specifications. The offered products meet regulatory compliance which is guaranteed according to the IATF 16949 and ISO 9001 certificates. offered services: our customers benefit from ABRASCH as a reliable and solution-oriented partner, building bridges between experts in the field, which results in reducing time to market, shorten their supply chains and improve the performance of their components.
CUNESOFT, A PHLEXGLOBAL COMPANY

Germany

Cunesoft offers a ready to use, pre-validated and highly secure cloud based regulatory compliance suite for Life Science Industry. This includes solutions like: eCTD, IDMP, RIM, RDMS, SOP, Data Mining and others. Our software has been built to fulfil regulatory needs holistically and end to end. Our vision is to keep it as simple as possible while delivering compliance and fulfilling FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.
KLOTZ GRASSINGER GRUPPE

Germany

Distinguished by completely digital machine technology (IKA®) and perfect cGMP compliance, the KLOTZ GRASSINGER group of companies are medium-sized German enterprises that specialise in the development and production of all types of liquids applied to the skin. Our company remains resolute in the face of uniformity and the desire to follow the latest trends as it seeks to set standards with products and processes that are committed to sustainability. Thanks to our machine technology (IKA®), we are able to develop products tailored to your specific needs within the shortest possible time, to document them as pilot runs ready for the market and, if successful, to produce them in large series. Our quality standards are to your benefit: All our production processes are internally validated and externally certified according to the latest cGMP guidelines. Thus, we fulfil all regulatory obligations from the EU/U.S. FDA/CHINA/JAPAN and elsewhere.
ARDUVERE GMBH

Germany

Arduvere GmbH is a privately owned, internationally active company, which was founded in 2015 in the North of Germany. Together with our team of highly specialized developers, we focus on the development of cosmetic care products of the highest quality in cooperation with various German cosmetic research centers and medical universities. Our guiding principle is, that only raw materials are used that meet our very highest quality and safety criteria and whose overall safety and effectiveness have been proven by corresponding practical studies. Implementing this maxim in every detail is a requirement and incentive for all employees in all specialist departments of our company. Our production- facilities are equipped with completely digital machine technology (IKA) and perfect cGMP compliance. All our production processes are internally validated and externally certified according to the latest cGMP specifications, DIN EN ISO 22716 and DIN EN ISO 9001. This means that we not only fulfil all European regulatory obligations but also those of the USA (FDA), China, Japan and many other countries. Our production is also certified according to the COSMOS standard for controlled natural and organic cosmetics (ECOCERT, BDIH). For all questions, me and our team are always at your disposal and look forward to hearing from you. With kind regards ARDUVERE GERMANY GMBH Frank Metzkes frank.metzkes@arduvere.de www.ARDUVERE.de

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Regulatory compliance - Germany

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5 Companies