Karine Faller

•Follow up of global project (new branding), •Follow up of development projects (IVD automates, small instruments ; Involvement in risk analysis team following the NF EN ISO 14971:2009, launch of products in USA), •Watch cell representative, •Vigilance, •Internal audit, •Studies & Up-date of regulatory texts (WEEE, RoHS), •Registration (CE-marking, Pacific Asia, Australia, etc.).

•Setting-up of a new process to improve the normative and regulatory watch cell, •Watch cell representative, •Follow up of the impact due to the handed over data & texts, •Follow up of projects (Regulatory affair representative, for equipment’s matter), •Studies linked with in vitro diagnostic appliances: 1998/79/EC directive (IVDMD), 2002/95/EC directive (RoHS) and worldwide equivalent legislations, 2002/96/EC directive (WEEE), 2006/66/EC directive (EU batteries), seism, labelling, time’s represen

•Coordination of the update of the documentation according to the 93/42/CE medical directive, •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 training for the use of this da

Corrosion studies about alloys used in biological medium, at an overall level and at the phases’ level •Project’s management: Planning, choice of the tests (electrolysis, re-passivation, cell culture, mechanical characterization), evaluation of the costs, Follow up, English report, •Work on titanium based alloys, stainless steel, shape memory alloys, •Management of teams for mini projects

Speciality in Biomaterial

in composites, ceramics, alloys, polymers, micro-electronics, in materials resistance, mechanic, chemistry,