Schweigert Medizintechnik
Medical Technology · Heidekreis
Schweigert Medizintechnik is a medical technology company based in Heidekreis, Germany.
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Schweigert Medizintechnik – Address & Contact
Schweigert Medizintechnik Overview
Schweigert Medizintechnik is a medical technology company based in Heidekreis, Niedersachsen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
Schweigert Medizintechnik, as a medical technology company, offers solutions for medical facilities, hospitals and practices. All products must meet the requirements of the EU Medical Device Regulation (MDR 2017/745) and bear the CE marking.
About Schweigert Medizintechnik
We are looking for Sie: employees im Außendienst (m/w/d)
Location & Contact
Schweigert Medizintechnik can be reached at the following address: Walsroder Strasse 8, 29683 Heidekreis. For current information and enquiries, please contact the organisation directly.
More information: Medizintechnik in Niedersachsen or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie Schweigert Medizintechnik have been required to comply with the EU Medical Device Regulation (MDR 2017/745) since May 2021, which has significantly raised the requirements for clinical evidence, post-market surveillance and traceability compared to the previous Medical Devices Directive (MDD). The regulation requires the unique identification of every medical device via the Unique Device Identification (UDI) system and registration in the European database EUDAMED.
Branche & Marktumfeld
With over 250,000 employees and a revenue of approximately 38 billion euros, the German medical technology sector is among the most innovative industries. Schweigert Medizintechnik in Heidekreis is part of this ecosystem. Germany is the third-largest medical technology market worldwide after the USA and China. Over 90 per cent of the approximately 1,500 medical technology companies are small and medium-sized enterprises (SMEs), which are often leaders in specialised niches.
Qualitätsmanagement & Zertifizierung
For the manufacturing and distribution of medical devices, a quality management system in accordance with ISO 13485 is standard practice in the industry. The standard defines requirements for the development, production, installation and maintenance of medical devices. In addition, the MDR requires comprehensive technical documentation, clinical evaluations and systematic risk management in accordance with ISO 14971 throughout the entire product lifecycle.
Frequently asked questions about Schweigert Medizintechnik
What services does Schweigert Medizintechnik an offer?
Schweigert Medizintechnik konzentriert sich on the Lieferung einer Vielzahl of medizinischen Hilfswithteln and productsn, darunder carebetten, Badehilfen, Gehhilfen, Dekubitus-Hilfswithtel, inpatient and mobile Sauerstoffgeräte, Krankenfahrzeuge, Krankenpflegeartikel, Lagerungshilfen, Mobilitätshilfen and Toilettenhilfen.
Where is der Firmensitz von Schweigert Medizintechnik located?
Der Firmensitz of Schweigert Medizintechnik befindet sich in Walsrode, Niethesachsen.
Worauf legt Schweigert Medizintechnik Wert?
Sie betonen the zuverlässige Auftragsbearattung and pünktliche Auslieferung with einem Team of 17 Mitaratterinnen and Mitarattern sowie 10 Servicefahrzeugen. Reparaturen are in the eigenen Servicewerkstatt durchgeführt.
Was ist die EU-Medizinprodukteverordnung (MDR)?
Die MDR (Medical Device Regulation, EU 2017/745) is seit Mai 2021 the maßgebliche Verordnung for medical devices in the EU. Sie ersetzt the frühere Richtlinie 93/42/EWG and stellt strengere Anfortheungen an klinische Bewertungen, Post-Market-Surveillance and Rückverfolgbarkeit. company wie Schweigert Medizintechnik müssen the MDR-Konforwithät for all products afterweisen.
Was bedeutet CE-Kennzeichnung bei Medizinprodukten?
Die CE-Kennzeichnung bestätigt, thes ein Medizinprodukt the Anfortheungen the EU-medical devicesverordnung erfüllt. Für products the Risikoklassen Is, Im, Ir, IIa, IIb and III is the Einschaltung einer Benannten Stelle (Notified Body) erforthelich, the the Konforwithätsbewertung durchführt.
Welche Risikoklassen gibt es bei Medizinprodukten?
medical devices are in vier Risikoklassen eingeteilt: Klasse I (geringes Risiko, z.B. Verbandmaterial), Klasse IIa (withtleres Risiko, z.B. Hörgeräte), Klasse IIb (erhöhtes Risiko, z.B. Infusionspumpen) and Klasse III (hohes Risiko, z.B. Herzschrittmacher). Die Klassifizierung bestimmt den Umfang the Konforwithätsbewertung.
More Medical Technology in Heidekreis
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.