PROMOTEC-Medizintechnik GmbH
Medical Technology · Teltow-Fläming
PROMOTEC-Medizintechnik GmbH is a medical technology company based in Teltow-Fläming, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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PROMOTEC-Medizintechnik GmbH – Address & Contact
Website
PROMOTEC-Medizintechnik GmbH Overview
PROMOTEC-Medizintechnik GmbH is a medical technology company based in Teltow-Fläming, Brandenburg. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
PROMOTEC-Medizintechnik 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
PROMOTEC-Medizintechnik GmbH can be reached at the following address: An der Dahlewitzer Heide 11, 15827 Teltow-Fläming. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Brandenburg or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie PROMOTEC-Medizintechnik 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. PROMOTEC-medical technology GmbH in Teltow-Fläming 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 PROMOTEC-Medizintechnik GmbH
What does PROMOTEC-Medizintechnik GmbH do?
PROMOTEC-Medizintechnik GmbH is a company in the medical technology sector based in Teltow-Fläming. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is PROMOTEC-Medizintechnik GmbH located?
PROMOTEC-Medizintechnik GmbH is headquartered in Teltow-Fläming. More information can be found on the company's website.
In which area of medical technology is PROMOTEC-Medizintechnik GmbH active?
PROMOTEC-Medizintechnik 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.
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All Medical Technology in Brandenburg on Sanoliste — or discover all categories by federal state.