Fitbit LLC

• Ministerie van Volksgezondheid, Welzijn en Sport
  Pays-BasContacter l’autorité →

Dispositifs placés dans 27 pays

• Belgique7
• Allemagne7
• Espagne7
• France7
• Irlande7
• Pays-Bas7
• Norvège7
• Suède7
• Autriche6
• Italie6
• Portugal6
• XI6
• Tchéquie5
• Pologne5
• Roumanie5
• Luxembourg4
• Danemark3
• Finlande2
• Islande2
• Estonie1
• Grèce1
• Hongrie1
• Liechtenstein1
• Lituanie1
• Lettonie1
• Slovénie1
• Slovaquie1

3 contacts identifiés

• PJ
  PHAN Jeanie

  PCVRR
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• PHAN Jeanie
  ensuring the: - device conformity follows the QMS; - PMS is planned, documented, implemented and updated per device type for gathering, recording and analyzing data to: • update the risk management file • improve usability, performance, and safety of devices • detect any statistically significant increase in the frequency or severity of incidents - proper measures are taken if a serious incident or CAPAs are identified - a statement referred to in Section 4.1, Ch II of Annex XV is issued
  Masqué
• VASQUEZ Adam
  ensuring the: - technical file and the DoC are completed and kept up-to-date - PMS data is used to: • update the technical file, the IFU and labeling • update the clinical evaluation; • update the SSCP • report any statistically significant increase in the frequency or severity of incidents - regulatory bodies are informed if serious incidents or CAPAs are identified - reporting obligations referred to in Articles 87 to 91 of Regulation (EU) 2017/745 are fulfilled
  Masqué

• TÜV SÜD Product Service GmbH — 1 certificat — Fitbit
• Emergo Europe B.V. — représente — Fitbit
• PHAN Jeanie — Fitbit