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Iso 13485 certified - Service Provider - Germany

5 Companies

4 Products

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.
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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Iso 13485 certified - Service Provider - Germany

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5 Companies