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Hittech Prontor GmbH Overview
Hittech Prontor GmbH is a medical technology company based in Calw, Baden-Württemberg. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
Hittech Prontor 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
Hittech Prontor GmbH can be reached at the following address: Gauthierstrasse 56, 75323 Calw. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Baden-Württemberg or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie Hittech Prontor 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. Hittech Prontor GmbH in Calw 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 Hittech Prontor GmbH
What does Hittech Prontor GmbH do?
Hittech Prontor GmbH is a company in the medical technology sector based in Calw. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Hittech Prontor GmbH located?
Hittech Prontor GmbH is headquartered in Calw.
In which area of medical technology is Hittech Prontor GmbH active?
Hittech Prontor 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.
More Medical Technology in Calw
Medical Technology in Germany
Related areas in healthcare
Medical Technology in Baden-Württemberg
All Medical Technology in Baden-Württemberg on Sanoliste — or discover all categories by federal state.