CEFLA s.c.

SRN

IT-MF-000009228

Rôle

Fabricant

Pays

Italie

Nom de l'organisation

CEFLA s.c.

Numéro TVA UE

IT00499791200

EORI

IT00499791200

Date d'enregistrement

5 juil. 2021

Adresse

23/A, VIA SELICE PROVINCIALE 40026 IMOLA ITALIE

Téléphone

+39 0 542 65 31 11

Email

ceflaimola@cefla.it

Site web

www.cefla.com/

Nom

Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico

SRN

IT-CA-070

Téléphone

+39 06 5994 3199/ +39 06 5994 3207

Email

segr.dgfdm@sanita.it

• MONTOSI Silvia
  • Ensure that the reporting obligations of art. 87 to 91 are met by monitoring the QMS • Ensure that PMS obligations of art. 10, par. 10 are met by collecting data on the quality, performance and safety of devices; ensuring implementation and monitoring any necessary actions; • Ensure that the reporting obligations of art. 87 to 91 are met with regard to: Collection and analysis of reports of serious accidents (art. 87); Collection and analysis of data to generate trend reports (art. 88)
  Masqué
• MONTOSI Silvia
  • Ensure drafting of technical documentation and EU declaration of conformity • Ensure that obligations arising from PMS of art. 10 par. 10 are met with regard to technical documentation • Perform the registration of Cefla in Eudamed (art. 31 point 5). • Ensure timely updates on EUDAMED related to: all serious accident reports (art. 87); trend reports (art. 88); device registration (art. 29 point 4); PSURs; Safety Warnings (art. 89) • Ensure the compliance of devices before release
  Masqué
• PORISINI Agnese
  • Ensure that the reporting obligations of art. 87 to 91 are met by monitoring the QMS • Ensure that PMS obligations of art. 10, par. 10 are met by collecting data on the quality, performance and safety of devices; ensuring implementation and monitoring any necessary actions; • Ensure that the reporting obligations of art. 87 to 91 are met with regard to: Collection and analysis of reports of serious accidents (art. 87); Collection and analysis of data to generate trend reports (art. 88)
  Masqué

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• Italie399