Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices
I'm not keen on the terminology, but there are two parts:
Technical file: summary documentation (see STED)
Design dossier: detailed and comprehensive documentation of the design process and steps.
Class III
Technical file and Design dossier must be reviewed by NB before marketing
Class IIa/b
Technical file must be reviewed by NB before marketing
Design dossier may be reviewed as part of a review of your quality system
Class I (excluding measuring and sterile)
No NB review required before marketing
technical file/design dossier may be reviewed as part of a QMS review
I'm not keen on the terminology, but there are two parts:
Technical file: summary documentation (see STED)
Design dossier: detailed and comprehensive documentation of the design process and steps.
Class III
Technical file and Design dossier must be reviewed by NB before marketing
Class IIa/b
Technical file must be reviewed by NB before marketing
Design dossier may be reviewed as part of a review of your quality system
Class I (excluding measuring and sterile)
No NB review required before marketing
technical file/design dossier may be reviewed as part of a QMS review