What are the Requirements to Get ISO 13485 Certification in UAE?

To get ISO 13485 certification in UAE:

1. The client or organization’s first option is to hire an authorized certification body and begin implementing the quality management system to eliminate risks, increase standardization, and assure transparency. The following is a good strategy to maintain constant quality:

· Development and Design.

· Installations for Storage and Distribution.

· Management of medical devices.

· Technical assistance with medical devices.

2. After engaging our consultant to assist you with the certification procedure, you will receive a comprehensive proposal.

3. We will develop the project document to direct your efforts and endeavours toward this certification once we receive your confirmation.

4. We assist you in preparing the necessary documentation and records, and we also assign a professional project manager to oversee your efforts and pursuit of accreditation.

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