top of page
Doctor Operating CT Scanner

Medical Device

QA-Base team will help to set up a QMS that will allow the customer to supervise on all the aspects of the product and related processes, as manufacturing, quality control, approval of suppliers, monitoring of suppliers and way of productions, risk management, storage control, way of distribution, etc.
In parallel, and as continuance to the QMS system, our team will work and mange the processes of achieving regulatory approval, according to the customer goals and strategic targets.
Our team has expertise in managing and achieving regulatory approvals as:

  • ISO9001, ISO13485.

  • USA - 21CFR Part 820.

  • China - CFDA/NMPA, etc.

bottom of page