Medica Esens
Medical Technology · Wittmund
Medica Esens is a medical technology company based in Wittmund, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Medica Esens – Address & Contact
Medica Esens Overview
Medica Esens is a medical technology company based in Wittmund, Niedersachsen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
Medica Esens 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
Medica Esens can be reached at the following address: Am Benser Tief 1, 26427 Wittmund. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Niedersachsen or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie Medica Esens 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. Medica Esens in Wittmund 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 Medica Esens
What does Medica Esens do?
Medica Esens is a company in the medical technology sector based in Wittmund. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Medica Esens located?
Medica Esens is headquartered in Wittmund. More information can be found on the company's website.
In which area of medical technology is Medica Esens active?
Medica Esens 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.
Medica Esens on social media
Medical Technology in Germany
Related areas in healthcare
Medical Technology in Niedersachsen
All Medical Technology in Niedersachsen on Sanoliste — or discover all categories by federal state.