Grosche Röntgenbedarf GmbH
Medical Technology · Bottrop
Grosche Röntgenbedarf GmbH is a medical technology company based in Bottrop, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Grosche Röntgenbedarf GmbH – Address & Contact
Website
Grosche Röntgenbedarf GmbH Overview
Grosche Röntgenbedarf GmbH is a medical technology company based in Bottrop, Nordrhein-Westfalen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
Grosche Röntgenbedarf 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
Grosche Röntgenbedarf GmbH can be reached at the following address: Hauptstrasse 75, 46244 Bottrop. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Nordrhein-Westfalen or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie Grosche Röntgenbedarf 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. Grosche X-raybedarf GmbH in Bottrop 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 Grosche Röntgenbedarf GmbH
What does Grosche Röntgenbedarf GmbH do?
Grosche Röntgenbedarf GmbH is a company in the medical technology sector based in Bottrop. The company develops, manufactures or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Grosche Röntgenbedarf GmbH based?
Grosche Röntgenbedarf GmbH is based in Bottrop. Detailed information can be found on the company website.
In which area of medical technology does Grosche Röntgenbedarf GmbH operate?
Grosche Röntgenbedarf GmbH operates in the medical technology sector and offers solutions for healthcare facilities, hospitals and practices. The exact areas of activity can be found on the company website.
What is the EU Medical Device Regulation (MDR)?
Die MDR (Medical Device Regulation, EU 2017/745) ist seit Mai 2021 die maßgebliche Verordnung für Medizinprodukte in der EU. Sie ersetzt die frühere Richtlinie 93/42/EWG und stellt strengere Anforderungen an klinische Bewertungen, Post-Market-Surveillance und Rückverfolgbarkeit. Unternehmen wie Grosche Röntgenbedarf GmbH müssen die MDR-Konformität für alle Produkte nachweisen.
What does the CE marking mean for medical devices?
The CE marking confirms that a medical device meets the requirements of the EU Medical Device Regulation. For products in risk classes Is, Im, Ir, IIa, IIb and III, the involvement of a Notified Body is required to carry out the conformity assessment.
What risk classes exist for medical devices?
Medizinprodukte werden in vier Risikoklassen eingeteilt: Klasse I (geringes Risiko, z.B. Verbandmaterial), Klasse IIa (mittleres Risiko, z.B. Hörgeräte), Klasse IIb (erhöhtes Risiko, z.B. Infusionspumpen) und Klasse III (hohes Risiko, z.B. Herzschrittmacher). Die Klassifizierung bestimmt den Umfang der Konformitätsbewertung.
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Medical Technology in Germany
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Medical Technology in Nordrhein-Westfalen
All Medical Technology in Nordrhein-Westfalen on Sanoliste — or discover all categories by federal state.