Instrutec GmbH
Medical Technology · Vorpommern-Greifswald
Instrutec GmbH is a medical technology company based in Vorpommern-Greifswald, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Instrutec GmbH – Address & Contact
Website
Instrutec GmbH Overview
Instrutec GmbH is a medical technology company based in Vorpommern-Greifswald, Mecklenburg-Vorpommern. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
Instrutec 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
Instrutec GmbH can be reached at the following address: Binning 8, 17367 Vorpommern-Greifswald. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Mecklenburg-Vorpommern or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie Instrutec 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. Instrutec GmbH in Vorpommern-Greifswald 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 Instrutec GmbH
What does Instrutec GmbH do?
Instrutec GmbH is a company in the medical technology sector based in Vorpommern-Greifswald. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Instrutec GmbH located?
Instrutec GmbH is headquartered in Vorpommern-Greifswald. More information can be found on the company's website.
In which area of medical technology is Instrutec GmbH active?
Instrutec 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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Medical Technology in Mecklenburg-Vorpommern
All Medical Technology in Mecklenburg-Vorpommern on Sanoliste — or discover all categories by federal state.