Precisis AG
Medical Technology · Heidelberg
Precisis AG is a medical technology company based in Heidelberg, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Precisis AG Overview
Precisis AG is a medical technology company based in Heidelberg, Baden-Württemberg. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
Precisis AG 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
Precisis AG can be reached at the following address: Hauptstraße 73, 69117 Heidelberg. 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 Precisis AG 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. Precisis AG in Heidelberg 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 Precisis AG
What does Precisis AG do?
Precisis AG is a company in the medical technology sector based in Heidelberg. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Precisis AG located?
Precisis AG is headquartered in Heidelberg. More information can be found on the company's website.
In which area of medical technology is Precisis AG active?
Precisis AG 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 Heidelberg
Medical Technology in Germany
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Medical Technology in Baden-Württemberg
All Medical Technology in Baden-Württemberg on Sanoliste — or discover all categories by federal state.