Results for

Service Provider - Iso 13485 certified

9 Companies

4 Products

EUROGENTEC

Belgium

Eurogentec S.A., part of Kaneka Corporation, is a leading supplier of specialty products and custom services. Our Life Science Research, Diagnostic services and GMP BioManufacturing Business Units provide high quality products to support scientists involved in the Life Science Research, biotechnology, diagnostic and pharmaceutical markets. Eurogentec is fully ISO 9001, ISO 13485 certified, cGMP accredited by the Belgian Ministry of Health and approved by the US FDA for the commercial manufacturing of a biologic for the US market. The Life Science Research BU provides trusted reagents and services for Genomics and Proteomics. The Eurogentec's Diagnostic Services Business Unit guarantees high quality GMP components dedicated for diagnostic applications. As a GMP accredited manufacturer of parenteral biologics since 1994, Eurogentec's GMP Biomanufacturing Business Unit develops and produces material for clinical trials and commercialization.
SHP STERILTECHNIK AG

Germany

SHP Steriltechnik AG is an established company in the field of steam sterilisation equipment for more than 14 years. The Laboklav autoclave series is available to the customer according to their individual requirements and dimensions. A manufacturer's warranty of up to five years and numerous accessories as well as a range of spare parts round off the service spectrum. Investments in research, development and marketing led to product development in the medical sector. All products are ISO DIN 9001: 2015 and ISO DIN 13485 certified and TÜV tested. In 2020, the company received an award in 2020 for being the best German manufacturer of steam sterilisers. Memberships exist with the SPECTARIS association. Professional Association of Analysis, Bio- and Laboratory Technology and the Association of Wholesale and Foreign Trade in Nursing and Laboratory Supplies. The SHP Steriltechnik AG group also includes two companies that stand for sustainability, recycling and environment.
LILA GMBH - SPEZIALIST FÜR INDIVIDUELLE LÖSUNGEN IN DER LASERPRÄZISIONSBEARBEITUNG

Germany

SPECIALIST IN INDIVIDUAL SOLUTIONS FOR LASER PRECISION FINISHING. LILA GmbH has been active as a specialist in laser precision finishing for more than 25 years. In addition to fine cutting and precision drilling, precision laser welding is a particular expertise. A wide range of metals and ceramic materials are processed on 25 fixed bed and fibre laser systems. Quality assurance at the highest level is obligatory at LILA, which is why all processes are certified both according to DIN EN ISO 9001 and according to the DIN EN ISO 13485 medical standard. Medical cannulas, measurement electrodes, surgical instruments, components for sensitive gauges or complex components for precision operations are standard metal workpieces that are manufactured at LILA. LILA is the market leader in the field of thick ceramics in particular, and can process material thicknesses of 0.1 mm–27 mm. The range of applications includes indexable inserts, sieves for industrial fine grinding mills, blades for medical shears and knives, bearings for Formula 1 vehicles, satellite technology and apertures for cameras and measurement systems. As LILA is active in quality-sensitive sectors, such as medical technology, sensor systems or aerospace technology, absolute dimensional accuracy and reliability are some of the basic requirements in every project. And so it's a matter of course at LILA that all requests are processed with the same regard and care.

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FISCHER ANALYSEN INSTRUMENTE GMBH

Germany

FAN GmbH develops and distributes 13C and H2 breath-test devices. Furthermore, we are specialists in the area of 15N analysers and specialist scientific devices. We also provide support with instructions and literature for medical breath-test devices, CO2 breath-gas analysers, (helicobacter pylori) breath-test kits and substances, and for tracer technology with stable oxygen and carbon isotopes. Our company is certified in accordance with EN ISO 13485: 2003 + AC: 2009

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TRINON TITANIUM GMBH

Germany

Trinon Titanium, with its head office in Karlsruhe, has been involved in machining metals, especially titanium and titanium alloys, since 1993. With over 200 manufacturing employees, we can offer the highest quality and short delivery times. We are certified in accordance with DIN EN ISO 13485 and EC Directive 93/42 EEC. Thanks to considerable materials storage capacity directly at the production site, we can deliver various titanium alloy products quickly.

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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

All the products for "iso 13485 certified"

MDR Technical Documentation

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MAXWELL COMMUNICATION GROUP

Italy

Maxwell Group is an independent ISO certification and business management system consultancy. The group is formed by highly-qualified staff specialised in ISO certification and in particular ISO 9001, ISO 14001 and ISO 18001 certification.
LACAQ

France

The company LACAQ, is a Service Provider, which operates in the Business Consultancy industry. It also operates in the iso 9001 certification, and Certified auditors industries. It is based in Lescout, France.
POLYTECH GROUP

Russia

POLYTECH Group provides services in the area of quality control and certification of products, advises companies that implement projects in Russia, Kazakhstan, and other EEU countries on technical regulation. The company has been working in the field of conformity assessment since 2013 and offers to organizations its services on quality certification of products, machinery, and installations, and on certification of construction equipment conformity with the applicable standards. POLYTECH Group experts test and examine the quality of products, including those intended for use at hazardous industrial facilities. POLYTECH Group helps manufacturers and importers, engineering companies and operating organizations in supplying industrial equipment to the territory of EEU member states: —develops strategies to certify the quality of packaged units; —performs quality control and certification for compliance with the requirements of the Technical Regulations of the Customs Union (TR CU); —tests and examines the machines and equipment for issuing certificates and declarations of conformity; —prepares technical datasheets, strength designs, and other documents in compliance with the applicable laws; —translates documentation into Russian; —clarifies the provisions of applicable industrial safety standards and regulations. POLYTECH Group helps obtain the necessary certificates, permits, and approvals quickly and at a reasonable price, overcome regulatory barriers.

All the products for "iso 13485 certified"

Declaring of conformity

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Service Provider - Iso 13485 certified

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9 Companies