Mefatech GmbH

Medical Technology · Offenbach

Mefatech GmbH is a medical technology company based in Offenbach, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).

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Mefatech GmbH – Address & Contact

Phone

Website

Address

Zeppelinring 17B
63165 Offenbach

Mefatech GmbH Overview

Mefatech GmbH is a medical technology company based in Offenbach, Hessen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.

Products & Solutions

Mefatech GmbH offers solutions as a medical technology company for medical facilities, clinics and practices. All products must meet the requirements of the EU Medical Device Regulation (MDR 2017/745) and bear the CE marking.

Location & Contact

Mefatech GmbH can be reached at the following address: Zeppelinring 17B, 63165 Offenbach. For current information and enquiries, please contact the company directly.

More information: Medizintechnik in Hessen or all Medizintechnik in Germany on Sanoliste.

Medizinprodukte-Regulierung (MDR)

Medizintechnikunternehmen wie Mefatech GmbH müssen seit Mai 2021 die EU-Medizinprodukteverordnung (MDR 2017/745) erfüllen, die deutlich strengere Anforderungen an klinische Bewertungen, Rückverfolgbarkeit und Post-Market-Surveillance stellt als die vorherige Richtlinie. Alle Medizinprodukte benötigen eine CE-Kennzeichnung durch eine Benannte Stelle und müssen in der europäischen Datenbank EUDAMED registriert werden.

Branche & Marktumfeld

The deutsche medical technologybranche counts with over 250.000 employeesn and a Umsatz from rund 38 Milliarden Euro zu the innovativsten Industriezweigen. Mefatech GmbH in Offenbach is Teil dieses Ökosystems. Germany is after the USA and China the drittgrößte medical technologymarkt worldwide. Über 90 Prozent the rund 1.500 medical technology company are kleine and mittelständische Betriebe (KMU), the häufig in specialiseden Nischen leading sind.

Qualitätsmanagement & Zertifizierung

Für the manufacturing and the distribution from medical devicesn is a quality managementsystem after ISO 13485 branchenüblich. The Norm definiert requirements at development, production, installation and maintenance from medical devicesn. Additionally fordert the MDR umfangreiche technische Dokumentation, clinical Bewertungen and a systematisches Risikomanagement after ISO 14971 over the entire Produktlebenszyklus.

Frequently asked questions about Mefatech GmbH

What does Mefatech GmbH do?

Mefatech GmbH is a company in the medical technology sector based in Offenbach. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.

Where is Mefatech GmbH located?

Mefatech GmbH is headquartered in Offenbach. More information can be found on the company's website.

In which area of medical technology is Mefatech GmbH active?

Mefatech GmbH is active in the medical technology sector and offers solutions for medical facilities, clinics and practices. You can find the exact areas of focus on the company's website.