Karine FALLER

Dédicaced audit team/design transfer
Facilitator for customer audit
Internal auditor
Site registration
Contact with notified body

Q dokumentenlenkung
Qualification production et salles blanches

● New registration & renewal of authorizations (Europe, USA: 510K/BLA, Canada, Australia, Brazil, Colombia, Turkey, etc.),
● Preparation & Update of technical files including Labelling & Risk management file review, Submission of change control, CAPA handling…
● Revision of processes,
● Follow-up of development projects, including IVDR,
● Internal auditor acc. ISO 13485/ISO 9001,
● Regulation and standards follow-up worldwide

Coordination of QARA team

Coordinator of RA team
corportate activity in WDH group
Follow up of developement project ac 93/42/EC; ISO 13485; ISO 9001
Regulatory and quality advisor (MDD, R&TTE CE marking, 62304, ...)
Risk management team membre acc ISO 14971
Bioevaluation acc ISO 10993
Labeling validation
Internal auditor
supporting external audit (DGM/Presafe), solving non conformities
Improvment of the quality handbook

Regulatory and quality advisor
Follow up of developement project
Follow up of quality complaints
Risk management team membre
Internal auditor

Division IHD de Bio-Rad laboratories

Suivi des projets de R&D (input réglementaire)
Analyse de réglementations
Enregistrement

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RA specialist for IVD reagents & instruments

•Registration of new launched products and renewal of authorizations (Europe: EC Design Examination certificates, CE-marking; India, Singapore, China, Taiwan, Australia, Brazil, Peru, Ecuador, Ethiopia, emerging countries, etc.),
•Re-organisation of the RA-Team: Revision of the vigilance process, the watch-up process, the CE-marking process, the content of the technical documentation, etc,
•Follow up of development projects, covering the US and RoW (IVD automates, IVD small instruments ; Involvement in risk analysis team following the NF EN ISO 14971:2009),
•Studies & Up-date of regulatory texts (WEEE, RoHS, US requirements),
•Follow up of global project (new branding),
•Watch-up representative,
•Vigilance representative for instruments.

3 activités:
-veille sur les réglementations sur les dispositifs médicaux de diagnostic in vitro
-Analyse de certains textes généraux
-Transfert des exigences réglementaires à la R&D et suivi de l'avancé des projets

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•Setting-up of a new process to improve the normative and regulatory watch-up cell,
•Watch-up representative,
•Follow up of the regulatory worldwide texts (US, Canada, Europe, China, etc.),
•Follow up of projects (Regulatory affair representative, for instruments’ matter) planned to be worldwide launched,
•Studies linked with in vitro diagnostic appliances: 1998/79/EC directive (IVDMD), RoHS (2002/95/EC directive, China, US, etc.) , WEEE (2002/96/EC directive), Batteries (2006/66/EC directive, US), seism (US & Japan), UL-mark, labelling, time’s representation, etc.,
•Up-date of manufacturing processes and chemical data sheets.

Relais réglementaire dans les projets de R&D (urologie)

•Coordination of the update of the documentation according to the 93/42/CE medical directive, in a corporate organisation,
•Update of Risk Management Files, according to ISO 14971:2007 standard / Identification and participation for the resolution of unconformities / Participation on the writing of tests’ procedures to answer to the new specifications,
•Follow up of projects (conception, testing steps, prototypes, production, post market),
•Follow up of the implementation of a new database / Local trainer,
•Involvement in regulatory activities (labelling validation, work on indication for use),
•Involvement in Audit (FDA-audit, DGM audit)