CE / FDA / CFDA
As part of our services QA-Base team will support and help managing all required documentation, submission paperwork, communication, etc with different notified body in order to receive the required CE/ FDA/ CFDA certification.
Part of the processes will include preparing and submitting technical files to the relevant NB (Notified Body/ Authorized representative ) and will manage all communication including Audit (internal/ external), guidance with regards corrective actions, and all related processes until receiving the required certification and approval for sales in the relevant markets.
** all documentation related to the above processes will be the customer property and will be implemented in the customer IT/ database system.
Part of the document will be:
Quality manual and policy, document related to ISO9001, ISO 13485, or other required ISO/ standards, document related to CE/ FDA / CFDA/ AMAR etc, training documents, management review documents, paperwork related to internal and external audits, etc.