Services

CE Auditor - Contractor

mi-CE consultancy can act as a contractor for Notified Bodies to execute Notified Body MDD/IVDD complaince audits and to executed full scope MDD design history file reviews and list B IVDD technical dossier reviews.

 

  • Full scope MDD, including Annex II audits and full design dossier reviews, as well as Annex V complaince audits and Annex III, or VII technical file reviews.

 

  • Full scope IVDD, including Annex IV audits and Annex III.6 design dossier reviews for self testing devices and Annex II List B technical file reviews.

 

 

mi-CE consultancy can act as a contractor for accreditation bodies to execute audits for the quality management systems standards ISO 9001:2008 and ISO 13485:2003.

 

Accordingly mi-CE consultancy can execute contractor audits under the Canadian requirements, ISO 13485:2003 under CMDCAS, and according to the Taiwan regulation as well.