Information about the company
Founded by Carine Grelait, by self entrepreneurship, Expert Quality Med Dev intends to address real issues met by industrialists that do not necessarily have access to the appropriate resources.
"After several years of experience and training as Quality Engineer New Product Development (R&D department in an international company, one of the medical device industry leaders), I noticed that companies often need expertise or skills, about very specific issues, in a very short time window and/or without considerable expenses.
That is why I offer my services for specific issues and in short term notice: simple advice or true partnership, services will be adapted to the true needs of industrialists."
Carine Grelait, Franche-Comté, France
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/