Results for

Iso 13485 certified - Germany

15 Companies

4 Products

PRODUCTION IN TIME ZERSPANTECHNIK UND HANDELS GMBH

Germany

PIT means Production In Time and stands for quality-conscious just-in-time production in the CNC turning industry. PIT produces absolute high-end precision and items only leave our factory if they can meet this standard. PIT GmbH is one of the smaller SME companies in this industry that have been successfully certified to ISO 9001, IATF 16949 and ISO 13485. Feasibility analysis: This important tool is the cornerstone for every single project that starts in our company. Precise piece time calculation: The determination of cycle times influences the process cycle immensely. A professional approach involving the expertise of experienced employees is a matter of course for us. Detailed and fair calculation: Direct and open communications with suppliers as well as customers should not be neglected in pricing. We have been successfully working with various suppliers of raw materials and tools for years and feel their trust. Offer development: The use of professional “requirements engineering” is the basis for the preparation of an offer. No offer leaves our company before it has been personally coordinated with our customers. Project planning & Development: With the application of the APQP process, we steer our projects to success in a targeted manner. The individual milestones are closely tracked and always completed with professional dedication.

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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.
BIOCHEM BERNBURG GMBH

Germany

BIOCHEM Bernburg GmbH was established in 1991 as a trading and manufacturing company. Our main areas of expertise are now the manufacture of dialysis products, nutritional supplements and industrial cleaners as well as the procurement and supply of raw materials for the manufacture of pharmaceuticals, foodstuffs, cosmetics and chemicals. We have been manufacturing dialysis concentrates since 1998. Our company is IFS (Global Food Standard) and EN ISO 13485 certified. We also work in other production areas as a contract manufacturer for food, feed, fishkeeping and chemical products. We mix, fill and assemble solid and liquid products, also in compliance with BIO/Öko certification (DE-ÖKO-034). Since 2020, we have also been manufacturing hand and surface disinfectants and selling a range of medical products including medical disposable masks and coronavirus antigen tests.
DMB APPARATEBAU GMBH

Germany

Sensitive medical devices require safe, reliable, reproducible and rapid sterilisation processes. DMB Apparatebau GmbH offers the optimum solution for the medical device industry, the pharmaceutical industry and other sectors requiring safe, cost-effective and rapid sterilisation of their products. Our experience enables us to assist you any time in finding your customised solution. With OVER 60 YEARS OF EXPERTISE IN ETHYLENE OXIDE STERILISATION, DMB Apparatebau is characterised by comprehensive expertise in the areas of customer-specific development, plant construction and EO contract sterilisation. Our sterilisers are used all over the world. Since 2003, DMB has been conducting contract sterilisation to make the procedure accessible to a larger group of customers. The speciﬁc requirements of our customers are the driving force behind ongoing further development. All activities are part of the QMS and satisfy the requirements of the templates for the applicable standards.

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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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CANNBRO TECHNOLOGY GMBH

Germany

CannBro Technology GmbH is a company that concentrates on cannabis vapourising devices such as 510 atomisers, 510 batteries, disposable flat pens, packaging and oil filling machines. The company was founded in 2019 and has its headquarters in Shenzhen, China. CannBro has its own research and development centre, a factory in Shenzhen and sales offices in North America and the EU. In 2022, the company was designated in China as a "State High Tech Company" because of its professional technology and the patents that CannBro have introduced to the industry. Their founding principle is "high quality, more success for the customer". CannBro has supplied cannabis vapourising devices and solutions to 80 markets across the world including the USA, Canada, the EU, Great Britain, Australia and Thailand. CannBro has a top-quality factory. We comply with ISO 9001, ISO 14001 and ISO 45001. Additionally, CannBro is certified according to GMP and ISO 13485, which allows us to produce medicinal devices. CannBro knows that every market wants to have their own colours. For this reason, CannBro has built the largest customisation centre that brings together screen printing, painting, coating, foil embossing and heat transfer. Whatever you want, we make it happen! CannBro is ready to support and serve our EU customers; helping them do more and having more success for their customers.

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DÜRR TECHNIK GMBH & CO KG

Germany

Dürr Technik – Inspiring With Green Air. "We are one of the pioneers of the environmentally friendly, oil-free air compressor technology. For decades, we have supplied our customers with innovative products, that provide high-quality, sustainable compressed air." A company of the globally operating Dürr Group. Dürr Technik belongs to the Dürr corporate group, with global subsidiaries and partners. The headquarters is located in Bietigheim-Bissingen, in one of the most innovative industrial regions of Germany. We've been dealing in compressor and pump technology for over 40 years. This extensive experience benefits our customers today. An innovative Development department, state-of-the-art production facilities and a certified quality management system according to standards such as ISO 9001, ISO 13485 and ISO/TS 22163 provide us with optimal conditions for meeting even the most demanding customer requirements. Our work is distinguished by experience, quality and precision. Close customer relationships are therefore just as important for us as the products themselves. Through personal consulting, we guarantee to find or develop the best product from our portfolio for every customer. Our product philosophy: High-tech for the highest requirements. With our oil-free compressors and vacuum pumps, we offer a wide range of premium products for the widest range of market segments. Whether a standard range or custom-built – our quality standard always remains just as high.

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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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MCD MEDICAL CARE DENTAL GMBH

Germany

MCD Medical Care Dental GmbH is your reliable partner for medical single-use products for the care, dental, laboratory, pharmaceutical and food industry sectors. As a registered manufacturer of medical and protective products, we supply businesses with our strong brand NITRAS MEDICAL. Our large storage spaces covering more than 10, 000 square metres, guaranteeing maximum availability for our products. Thanks to our excellent contacts with the far east, we are able to offer you a wide range of NITRAS MEDICAL products. Our own sales office in Shanghai supports our communication with the suppliers and monitors on-site quality controls in order to ensure the highest possible product quality – an advance you benefit from. We are certified in accordance with EN ISO 9001 and EN ISO 13485. Put together, our management team possesses more than 50 years of experience in the sector. See for yourself – we look forward to hearing from you!
BIO-3 IMPLANTS GMBH

Germany

Bio3 Implants GmbH - German manufacturer of dental implants and supra structures. Certified according to ISO 13485, CE, Free sale certificate. We provide life warranty. Titanium Grade 4 implants Bio3 Implants GmbH is a German company, which offers the dentists the best solutions of the highest quality and accuracy in implantology. We develop, produce and implement reliable and quality implant systems of premium line with conical connection. Bio3 Implants team tends to make implantation simple, easy, high-quality and highly gentle for the patient. To achieve this goal the company develops innovative premium quality products as well as provides its customers with a high standard service. Each Bio3 Implants product is assigned with a unique serial number that allows tracking the history of the product manufacturing from the first to the final stage. Bio3 Implants provides a lifetime warranty on all its products. Each implant includes Warranty Card, Product certificate and manual for the patient.

VOGT MEDICAL VERTRIEB GMBH

Germany

Vogt Medical Vertrieb GmbH operates internationally since 1991 and has an outstanding experience in development, manufacturing and distribution of German-quality medical disposable products. The ultimate goal of Vogt Medical team is to create high-quality products, which are delivered through the chain of our trusted partners to the people in need. This includes safety equipment to protect medical personnel, disposables for medical manipulations in the hospital and at home, as well as personal protection equipment for medical and civil use to protect from cross contamination. We are able to efficiently meet all of your requirements in 70 countries around the globe. More than 350 professionals around the world are there for you every day to ensure that the patient’s quality of life is significantly improved and that the recovery progresses rapidly, that doctors are able to carry out their work efficiently and safely and that the economic burden on the healthcare sector is relived. Our quality management system is certified by TÜV SÜD on a regular basis according to the DIN EN ISO 9001 and DIN EN ISO 13485 standards as proof of the performance of our quality management. The Vogt Medical management is constantly developing new technologies with only one objective: to offer patients and healthcare professionals more safety.
ALPHA DENT IMPLANTS GMBH

Germany

Alpha Dent Implants est une société développée, occupant une position solide dans le domaine de la conception et de la fabrication des produits d’implantologie dentaire. Un système innovant d’implants dentaires Alpha Dent Implants a été élaboré à la base d’une longue expérience et des recherches scientifiques des leaders mondiaux de l’implantologie. Grâce à la technologie de précision dans la fabrication et le traitement spécial de la surface des implants leur haute ostéo-intégration est atteinte dans les plus brefs délais. Alpha Dent Implants possède un système de contrôle minutieux de la qualité de ses produits qui correspond aux exigences de tous les standards dans ce domaine : standard ISO 13485 dans le cadre du système d’évaluation de la correspondance à la Norme européenne des produits médicaux ; les produits sont certifiés en UE et dans plusieurs pays du monde. L’implantation est le domaine le plus demandé en chirurgie dentaire. L’implantologie a révolutionné la réhabilitation des patients aux défauts de la denture en rendant leur qualité de vie grandement meilleure. La société Alpha Dent Implants aspire à élargir les possibilités des orthodontistes et propose un système d’implants Alpha Dent Implants, créé à la base des technologies les plus modernes et les dernières recherches en implantologie dentaire. Le large assortiment de nos produits donne la possibilité de l’approche individualisée du traitement des patients, en garantissant un magnifique côté esthétique.

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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.
B.A.B. AGRARBERATUNG GMBH

Germany

At B.A.B. At AGRARBERATUNG GmbH, our aim is to offer our customers a wide range of healthy energy drinks and other beverages that boost their energy levels and make them feel refreshed and optimally hydrated without any side effects. In our drinks category, we offer Sprite energy drinks, Lipton Ice Tea energy drinks, San Pellegrino mineral water and more. These come from renowned brands whose products are tailored to the specific requirements of global customers. These manufacturing brands have a technologically advanced facility with high-performance machinery to produce the highest quality products to meet consumer demands.

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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

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Iso 13485 certified - Germany

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15 Companies