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Service Provider - Report on product safety

Service Provider
  1. MAZURKA SARL

    Luxembourg

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    MAZURKA specializes in the application of cosmetic product regulations for companies with branded cosmetics. It assists them launch and follow up cosmetic products in the European market to comply with EC regulation 1223/2009. The DIP required before marketing includes many elements defined by European legislation. It also offers assistance during inspection authority missions. Fully conversant with trace one software.

  2. TAOBÉ CONSULTING

    Belgium

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    If you want to sell your cosmetics in Europe and the United Kingdom it is vital that they comply with EU regulation (CE) 1223/2009, which applies in 31 EU countries and the UK. This is widely considered to be the strictest regulation in the world. There are numerous criteria to consider when assessing the compliance of cosmetic products for Europe, which requires a safety assessor to examine all the documentation covering the ingredients used in the product's composition. The safety assessor also studies relevant toxicological data in order to establish a cosmetic product safety report (CPSR). Only at the end of this assessment can the product information file be completed and the product labels reviewed to ensure they include all the requisite information. The final phase of every registration project is to submit the notification to the appropriate portal (CPNP and/or SCPN). Taobé Consulting is cosmetic regulatory service provider with offices in Brussels (EU) and London (UK). We are experts at the registration of cosmetics in Europe and Great Britain. We create the CPSR, product Information File (PIF), check the formula, labels and claims for compliance. Taobé Consulting can also act as your EU and UK Responsible Person and notify your products on the CPNP and SCPN. In need of a regulatory service for another market? We’ll introduce you to one of our partners from our global network. Let’s talk! We are fluent in English, French, German, Spanish, Portuguese and Japanese.

  3. 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

  4. BMA TEXTILE SOLUTIONS

    United Kingdom

    BMA Textile Solutions was founded to serve clothing retailers and manufacturers supplying into the UK market. Our goal is to consistently exceed the expectations of our customers whilst delivering professional, innovative and creative solutions that help them source high quality products, delivered on time and at a competitive price. Founded by Hakan Avci, with 16 years experience in high street and supermarket garment sourcing, manufacturing, quality and compliance, our services are summarised below. SOURCING * Providing appropriate sourcing solutions for retailers/suppliers for products such as: Fabric, Socks & Seamless, Jersey wear, Woven wear, Knitwear, Towels & Bathrobes * Production progressing and critical path management QUALITY * Establishing or supporting to develop quality systems and standards, technical advising * Inspection Facilities: Incoming material inspections, Factory in-line & AQL inspections, Warehouse quality & compliance inspections, In-store inspections * Investigating returns and claims; analysing and reporting * Refurbishment solutions * Delivering technical training including AQL and Fabric Inspection processes, and Product Safety * Custom made solutions COMPLIANCE * Evaluation and preparation of factories for audits such as SEDEX, BSCI, ETI, Technical assessments etc * Supporting for continual improvement in terms of audits and CAPs

  5. 360 AUTOMATIONS LTD

    United Kingdom

    We specialise in providing repair, service and upgrades to existing systems which are carried out by trained and fully qualified and experienced staff with electrical qualifications. For new installations 360 Automations will guide you through the choice of gates and automation and provide advice on planning issues thereafter a full installation service including groundworks, building and mains power supply to the gate by our qualified electricians with Part P certification and thereafter all on-going maintenance. We offer risk assessment, technical reports and safety advice for both direct customers and agents in the commercial and domestic sectors. Phil Bowring, the company’s founding director is one of this country’s most respected and experienced perimeter security and automation consultants. He has 29 years working in the gate and barrier automation Industry, his experience is second to none. Phil is a fully qualified electrical engineer (City & Guilds technician level) with a wealth of design engineering knowledge, project management and customer support experience: This, coupled with his knowledge of products, systems design and testing, H&S requirements and the Machinery Directive, means that with 360 Automations you will benefit from our comprehensive knowledge, and expertise, to ensure you have a safe and reliable system. We pride ourselves in offering a personalised service and guarantee to provide you with a good experience from initial enquiry to handover.

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  1. RENFREY REGULATORY & COMPLIANCE CONSULTANCY

    United Kingdom

    RR&CC.com provides an affordable solution to your regulatory issues regarding hazardous products. This includes classification of your products, labelling guides and Safety Data Sheet (SDS) authorisation (translation service into many languages also available). Comprehensive classification of mixtures using existing data or via calculation methodology where appropriate. Using expert judgement decisions based on sound scientific principles to provide accurate, relevant and clearly explained classification of mixtures. Clear concise reports (in your company formatting if requested) will provide suitable records should the method be challenged by authorities. Contact for a quote today to ensure ongoing compliance.

  2. MONDO ENGINEERING AND INNOVATION OY

    Finland

    Mondo E&I is a trade and engineering consultancy company with main focus of rare food products. We offer services to wholesalers, resalers, suppliers and producers. For wholesaler clients, Mondo E&I offer innovative PSA reports with new and feasible rare food products for a target market. We make regular inspections of production facilities for hygiene, safety and labor conditions.For producers and suppliers; Mondo E&I can act as representative and agent for your products in the target market. Thus, we form a reliable bridge between you and wholesalers. Mondo E&I also use cutting-edge food processing technology solutions for food drying and processing. We develop and intensify food processes for significant capacity increase and reduced unit production costs.Mondo E&I combine innovation in technical and trade details. We look forward for reliable, durable and efficient business relations with our clients.

  3. VERO SOLUTIONS

    United Kingdom

    VERO suite of solutions are designed to help you track key assets, including pallets, products and RTIs, monitor the safety of warehouse staff, and report and analyse critical data so that you can boost the productivity of your warehouse or logistics operation. VERO can also help you to automate data gathering, so that you can reduce the resources needed to manage your warehouse. VERO provides data that is simply unavailable from traditional warehouse management systems.

  4. GEBRÜDER BURGER GMBH & CO KG PRÄGEFOLIENFABRIK

    Germany

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    Gebrüder Burger GmbH & Co KG is aware of its social responsibility and meets the standards of international codes of conduct. Our corporate activity is based on applicable legal and ethical standards, with a particular emphasis on the well-being of our employees. In addition, we strive to protect the environment. The operation of our systems is inspected in line with legal provisions. We only use raw materials which are pre-registered or have already been registered. The same applies for our foils from sites outside the European Union. The foils themselves are classed as products in line with EU Regulation 1907/2006 dated 18th December 2006 and are not subject to mandatory registration. Our foils are primarily produced in Germany. For foils produced outside of Germany, we take care to ensure the same high standard of quality for raw materials and manufacturers.

  5. CRANAGE EMC & SAFETY

    United Kingdom

    At Cranage EMC and Safety, we provide laboratory testing services, field evaluation, technical assistance and certification for a wide range of industries across the UK. From baby toys to industrial machines Cranage supports corporate responsibility for product safety, identifying risk and advising on limitation, offering knowledge and technical expertise, and providing accredited testing facilities. The key to success and sustainability is to get us involved early in your project. We are a UKAS accredited testing laboratory (No.1833) with nearly 30 years experience in the conformity assessment business, Cranage has acquired a thorough knowledge of the standards, regulations and product approval requirements of many countries around the world. Using a UKAS accredited lab gives manufacturers assurance of reliable, consistent and accurate test procedures and results. We can offer EMC, product safety and environmental testing for a vast range of products. We specialise in testing medical devices against the group of standards under IEC 60601. We have experience of evaluating equipment to be used in the diagnostics, treatment or monitoring of a patient, or alleviation of disease, injury or disability. We are able to work with you to get your device compliant for the country in which it will be used, whether this is in Europe or worldwide. We work with our subsidiary company, Cranage Veritas, to be able to offer a range of additional services including NRTL inspection for the US