Independant CE technical file assessor- Medical device
Châtenay-Malabry
En résumé
Pharmacist- Medical device Technical file/ product Assessor- CE Mark
Entreprises
MD-EX
- Independant CE technical file assessor- Medical device
Autre | Châtenay-Malabry (92290)2017 - maintenantExternal Technical File assessor for class III / IIb/ IIa Medical Devices according EC Design-Examination and Type for Notify body- Règlement (UE) RDM 2017/745
Product reviewer :
MDS 1001 Devices incorporating medicinal substances
MDN 1204 Non-active non-implantable devices for wound and skin care
MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
MDN 1102 Non-active implants and long term surgically invasive devices - Intra-articular use
MDN 1103 Non-active dental implants and dental materials
MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed
MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
Pre-filled syringe for filling wrinkles
Devices manufactured using chemical processing
LNE
- Certification Project Manager- Technical file Assessor at LNE/G-MED French Notify Body
Paris2012 - 2017Certification project manager at LNE/GMED, French Notify Body - Conbined medical device refrent- Complex Medical devices Department :
In charge of the certification follow-up for a set of manufacturer
· Technical File assessor for class III / IIb Medical Devices according EC Design-Examination and Type
Examination : Filler, combined medical device, dental device, wound care,..
· Combined medical device referent
