Fitbit LLC

3 contacts identified

• PJ
  PHAN Jeanie

  PRRC
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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
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• 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
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• Ministerie van Volksgezondheid, Welzijn en Sport
  NetherlandsContact the authority →

Devices placed in 27 countries

• Belgium7
• Germany7
• Spain7
• France7
• Ireland7
• Netherlands7
• Norway7
• Sweden7
• Austria6
• Italy6
• Portugal6
• XI6
• Czechia5
• Poland5
• Romania5
• Luxembourg4
• Denmark3
• Finland2
• Iceland2
• Estonia1
• Greece1
• Hungary1
• Liechtenstein1
• Lithuania1
• Latvia1
• Slovenia1
• Slovakia1

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