LifeScan U.S. LLC

• DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
  AllemagneContacter l’autorité →

Aucun certificat enregistré pour ce fabricant.

Dispositifs placés dans 8 pays

• Autriche1
• Belgique1
• Allemagne1
• Espagne1
• France1
• Irlande1
• Italie1
• Portugal1

11 contacts identifiés

• GM
  GANNON Michael

  PCVRR
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• HK
  HORROCKS Kirsty

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• JN
  JANSSEN Nicole

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• MC
  MACKENZIE Cameron

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• MJ
  MACKENZIE Jennifer

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• SE
  SCHAFFERT Eva

  PCVRR
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• MACKENZIE Cameron
  Article 15. 3(a) The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
  Masqué
• MACKENZIE Jennifer
  Article 15 3(b). The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. 3(e). In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV (for IVDR) and of Annex XV (for MDR) is issued.
  Masqué
• GANNON Michael
  Article 15.3(a) The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. (Digital Representative) Article 15.3(c) The post-market surveillance obligations are complied with in accordance with Article 10(9) (for IVDR) and Article 10(10) (for MDR). Article 15.3(d) The reporting obligations referred to in Articles 82 to 86 (for IVDR) and Articles 87 and 91 (for MDR) are fulfilled.
  Masqué
• JANSSEN Nicole
  Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding regulatory requirements for medical devices in the Union.
  Masqué
• SCHAFFERT Eva
  Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding regulatory requirements for medical devices in the Union.
  Masqué

• LifeScan Deutschland GmbH — représente — LifeScan U.S. LLC
• GANNON Michael — LifeScan U.S. LLC
• HORROCKS Kirsty — LifeScan U.S. LLC
• JANSSEN Nicole — LifeScan U.S. LLC
• MACKENZIE Cameron — LifeScan U.S. LLC
• MACKENZIE Jennifer — LifeScan U.S. LLC
• SCHAFFERT Eva — LifeScan U.S. LLC