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passioPharm GmbH – Address & Contact
Website
passioPharm GmbH Overview
passioPharm GmbH is a medical technology company based in Merzig-Wadern, Saarland. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
passioPharm 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
passioPharm GmbH can be reached at the following address: Trierer Strasse 22, 66709 Merzig-Wadern. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Saarland or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie passioPharm 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. passioPharm GmbH in Merzig-Wadern 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 passioPharm GmbH
What does passioPharm GmbH do?
passioPharm GmbH is a company in the medical technology sector based in Merzig-Wadern. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is passioPharm GmbH located?
passioPharm GmbH is headquartered in Merzig-Wadern. More information can be found on the company's website.
In which area of medical technology is passioPharm GmbH active?
passioPharm 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 Merzig-Wadern
Medical Technology in Germany
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Medical Technology in Saarland
All Medical Technology in Saarland on Sanoliste — or discover all categories by federal state.