Nathalie Trétout

Trainer (n°84380795938) on ISO 14155, Clinical Evaluation and PMCF

Provide training, help & support for Medical Device manufacturers in Clinical Evaluation, PMCF process and all clinical operations related elements (ISO14155), due to change in regulation (MDR) and further update in regulation, to obtain and/or maintain CE mark.

Member of ISO / AFNOR group for reviewing ISO14155 and building the new ISO18969

Class IIb and III MD for dental and orthopedics implants. Provide help and support to define strategy and organization for Clinical Evaluation process and all clinical operations elements related to Clinical Investigations.

 Set up of the Clinical Affairs Department for Global D company, support structure and development of clinical activities for the other entities of the MENIX group. Ensure PMCF studies are set-up and running to achieve reporting objectives,

 Provide help & support to define strategy and organization for Clinical Investigation process and all clinical operations related elements, due to change in regulation (MDR 2017/745), to obtain and/or maintain CE mark.

Review Clinical Evaluation process and validation of CER/CEP and PMCF plans and reports.

Classe IIb and III Medical devices for orthopedic implants.

 Set up and development of the Clinical Research Department. General departmental responsibilities including resource allocation, training, contracts and budgets,

 Overall responsibilities for clinical studies over Europe, Asia and Pacific: set-up of clinical projects from study document preparation including protocol writing; Regulatory Submissions in accordance with GCP, local requirements, Standards, Directives and Guidelines; Investigator meetings, and all clinical project follow-up activities; managing Outsourcing when needed,

 Clinical studies: Post Marketing Surveillance for all company implants, collaboration with Orthopaedics departments from public and private practices,

 Clinical Evaluation: internal trainer, reviewer and approver for Clinical Evaluation & PMS reports, SOP update review as per change in requirement (MEDDEV 2.7/1 rev4)