ISO 13485:2016 Certification is a very essential Standard for medical device manufacturers.

It emphasizes on following the best quality practices for medical devices design and manufacturing companies.

10 Key Benefits on Implementation of ISO 13485:2016 Certification
1. Improve Credibility and Brand Image Gaining Customer Confidence
2. Gaining Customer Confidence
3. Enhanced safety and reducing potential hazards of using medical devices
4. User-Centered Approach to Product Development
5. Practice the Culture of Continuous Improvement
6. Ability to Monitoring the Performance and Compliance of the QMS System via external audit
7. Maintaining Consistent Quality throughout the phases of production and beyond
8. Reducing the risk of reputational damage to manufactures caused by product defects.
9. Standardized Certification Globally
10. Expand to potential markets Globally

Who is ISO 13485:2016 Certification the best fit for?
Organizations involved in one or several stages of a medical device lifecycle or a supplier or other external parties providing products to such organizations

Organizations involved in stages of medical device lifecycle
• Design and Development
• Production
• Storage
• Distribution
• Installation
• Servicing

Suppliers/external parties who provide products to medical organizations

• Raw Materials
• Components Sub-Assemblies
• Medical Devices
• Sterilization Services
• And more…
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For all your queries on ISO Certification in the UAE, contact us!
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