MMedical Devices

QABASA Professionals has been serving the medical device industry for more than a decade. We have extensive experience in helping medical device manufacturing companies across the world successfully enter and obtain market approval in the United States, Europe, Japan, Brazil and Canada. Whether it is for 510(k) submission, CE Mark, PMDR, cGMP compliance, ISO 13485 compliance or ANVISA approval, QABASA can provide you full scale services.

We can help your organization with

FDA Compliance

CE Mark/MDD/IVDD

ANVISA Approval

Health Canada Approval

PMDR Approval

ISO Compliance

Please refer to our medical devices section under services menu for more details.