Results for

Service Provider - Import-export medical devices

8 Companies

30 Products

TORNAGA BIOMEDICAL LTD.

United Kingdom

We are providing medical device Import Export Consultancy Brokerage Services Promotion and Advertisement Maintenance and Repair Device and Service Recommendation
TEMAS GROUP EXPORT PARTNERS

Turkey

As partners of Temas Group Export Partners, we specialize in helping businesses succeed in the global marketplace by finding new export customers, generating leads, and developing export strategies. Our carefully designed services ensure that our esteemed clients receive a unique and effective experience. With our experience in customs clearance, logistics, and foreign trade, we drive sales and help your business achieve success. Our broad selection of products caters to diverse needs, including textiles, medical equipment, machinery, mechanical engineering, industrial equipment, agricultural products, chemicals, plastic products, disposable tableware, packaging solutions, fruits and vegetables, and laser processing among other exceptional offerings. We export high-quality products from Turkish manufacturers to Europe. Please visit our website to explore the entire range of opportunities available to you. At Temas Group Export Partners, we prioritize customer satisfaction and make it the core of our business operations. Our team of experienced professionals is committed to delivering excellent services that are customized to meet your specific needs. We provide valuable support to develop and expand your business activities, leveraging our expertise in finding new customers, generating leads and promoting export development, to ensure you achieve your goals. If you require further information, please don't hesitate to contact us.

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MUSTANOGLU PROFESSIONAL MEDICAL EQUIPMENTS

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MEDIQUASAR CONSULENZA

Italy

With the experiences I acquired the following skills: to make/prepare the Clinical Evaluation Based On The Literature, to extension of an existing clinical evaluation ; to resolve the issues concerning the regulatory aspects of: classification of the specific type of the product, CE, marketing authorizations, import / export permits, verify the accuracy of labeling, compliance with the requirements of 'U.S. FDA 510 (k) Medical Device Submissions Requirements, preparation of the technical documentation for medical devices, etc.; to know the requirements on Clinical Investigations; to know the ISO 14155: 2012; to translate.
FASTACARE SERVICES LIMITED (FSL)

Cyprus

FastaCare Services Limited offers regulatory affairs support, local representative and training services to EU & non-EU based health & beauty products industries. We provide EU Authorized Representative and Responsible Person services to non-EU based medical device and cosmetics companies respectively. We provide a comprehensive export support services to EU based manufacturers of health & beauty products who want to maintain or expand distribution of their products to Canada, United States of America and Nigeria. Our services includes but not limited to: - Regulatory Affairs & Quality System Professional Training - Off & On-site - Canadian, US and Nigerian regulatory submission management for Human Medicines (Pharmaceuticals & Herbals), Veterinary Medicines, Medical Devices & Cosmetic Products - Canadian Importer of Records services for Herbal Medicines & Medical Devices - Nigerian Importer of Records & Representative services for Health & Beauty Products - Canadian Early Market Entry Support for Herbal Medicines & Medical Devices - Canadian & US GMP/Quality System regulatory inspection preparation & representation FastaCare Services Limited is an affiliate of Canadian and Nigerian based Reg-Affairs & QualiPractixis Inc. and FastaCare Therapeutics Nigeria Limited respectively.
CARDIMED B.V.

Netherlands

CARDIMED B.V. based with its head office in Maastricht, the Netherlands, has developed into a global purchasing organisation (GPO) for medical devices and pharmaceuticals. Our company consists of several divisions, such as cardiology, neurology, orthopedic, surgery, dental, wound care and sport care. We are in partner-/distributorship with international market leading medical manufacturers and suppliers all over the world. This together with our 25 years of experience in the medical field, we can offer the best quality products in line with the best service that our customers are looking for. Our group of companies consists of several locations in The Netherlands, Germany, USA, Turkey and Poland. Our products going to our valued customers in more than 50 countries around the globe.

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ZERO GROUP MEDIKAL TEKSTIL ITH. IHR. SAN. VE TIC. LTD. STI.

Turkey

The company ZERO GROUP MEDIKAL TEKSTIL ITH. IHR. SAN. VE TIC. LTD. STI., is a Multi-Category, which operates in the Import-export - medical and surgical equipment industry. It also operates in the hospital and medical laboratory equipment and supplies, medical devices, and plastic test tubes for laboratories industries. It is based in Antalya, Turkey.
MEDCOMBO

Spain

Medcombo is the main worldwide recognized virtual exposition for medical devices exhibitors. B2B platform dedicated to the mutual exchange of important information in the medical sector, it aims to eliminate physical and conceptual barriers to the spread of quality medical information. Born in 2018, its partners are companies listing products from all over the world (the majority are in China). Our goal its to create a virtual world in which there would not be necessary any more to spend a lot of efforts and money in trade fairs, but it will be possible to contact the desired company or person in charge to have information about a specific product. The registration will be free and it will be possible to contact suppliers from the very first moment.
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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Service Provider - Import-export medical devices

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8 Companies