About ISOMED Conseil
Training agency, we also work with AFNOR Competences.
A strong partnership is built with MD101, a solid and recognized network of MD industries, but not only.
Since November 2022, Carine Grelait is referenced as expert by BPI France, Medical Device DIAG (QMS and technical file).
Carine Grelait worked 4 years for Johnson and Johnson, in the R&D department of Codman NeuroSciences (one of Johnson and Johnson's companies). As Quality Engineer New Product Development, she coordinated and followed up quality aspect for medical devices development and Design Change projects (class IIa and implantable active), with embedded software and hardware.
Her responsibilities included:
· Documenting development and validation.
· Managing Design risk analysis activities (Risk Management File building, dFMEA and Software Hazard Analysis activities with technical teams).
· Assessing impacts on product's documentation after Design Changes.
· Building the Design History File for submission to FDA and BSI.
· Leading a project to baseline a high technology medical implant to IEC 62304.
Carine Grelait also worked on developing and validating software tools used to elaborate and verify medical devices.
Carine Grelait's working experience is available on Linked In : fr.linkedin.com/in/carinegrelait/