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Filling Out a Medical Form

Processes

We provide variety of QA processes, according to the customer requirements and regulatory status. We specialized in the Medical device arena, Digital health arena and factories/ industrial facilities arena.

Design strategy
per client

Each client/ product will require its specific strategy. In order to be focused, and build correct plan, and will be cost and time effective, for the client.

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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.

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QMS
 

Our team at QA-Base will help and support our customer will preparation, documentation, manage the IT system, implement, training and work according the quality system that will be built and implement in the customer internal system.

Audits

As part of the routine work, and managing regulatory processes, QA-Base team will guide and support the client with all issues and compliances with internal and external Audits.

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ISO9001/ ISO 13485/ ISO27001

Out team at QA-Base will help the client to build and organize its internal documentation system so it will comply with the ISO requirements around the world.

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Maintenance

As part, and in contingency, to the routine processes QA-Base team is providing to our clients, and after finalizing implementation of relevant processes as implementation of QMS, receiving CE/ FDA/CFA/AMAR/ etc, receiving the ISO certificate, supplier approvals, etc, we will provide routine support to the customer.

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