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Safety assessment - Service Provider - Germany

3 Companies

17 Products

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Belgium

COSMETIC PRODUCT SAFETY REPORT (CPSR) AND PIF CREATION

Belgium

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PPM COSMETIC GMBH

Germany

"Quality products from head to toe – and nose to paw". For more than 20 years, we have been your experienced partner for developing recipes, and for the production and filling of high quality cosmetics and care products. As a certified contract manufacturer, we offer everything from a single source: Product consultancy, recipe development, from manufacture to filling, packaging and logistics – all in compliance with all the relevant quality standards. Thanks to our many years of experience, we can offer consultancy services in skincare and body care (including creams, oils, lotions, soaps, serums, aerosols), haircare (including mousse, shampoo, serums), oral care (including mouthwash and mouth sprays, toothpastes/gum serums) and also for the pet care sector. Our range of services also includes the preparation of safety assessments and notifications. "The highest quality standards and tailored solutions". We set the highest standards for our products and services. We rely on our highly qualified staff, who always work in accordance with the cosmetics GMP certificate to ensure that we meet these standards. Our strengths lie in providing tailored solutions, creating high-quality products based on your ideas, marked with a label of your choice. We can also provide private labelling and direct shipping to customers. We devote our passion, skills and many years of experience to helping you create your dream product.

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ESIS GMBH

Germany

ESIS GmbH have long experience in rendering service in technical areas, NPP commissioning and operation, quality assurance, conformity assessment, safety analyze, design, licensing and also in the field of NPP Personnel Training. They were participants of international projects on NPP safety enhancement and creation of NNEGC Energoatom normative documentation, NNEGC Energoatom Personnel Training System creation and upgrading, creation of Product Conformity Assessment System of Energoatom, etc. The most part of specialists of ESIS GmbH have long experience in NPP operation (former Ukrainian NPPs employers). ESIS key experts earlier worked in NNEGC Energoatom, Ukrainian NPP Personnel Training and Licensing Department. They are the authors and participants of development of all standards of Energoatom and the Ministry of Fuel and Energy in the sphere of NPP personnel training.
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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Safety assessment - Service Provider - Germany

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3 Companies