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ISO – 13485 (Medical Devices)

ISO 13485 (Medical Devices) Certificate Consultation

Ensure Patient Safety & Global Regulatory Compliance
ISO 13485 is the gold standard for quality management in the medical device industry. It is a rigorous framework designed to ensure that organizations consistently meet customer and applicable regulatory requirements for medical devices. At MFT Global Consultancy, we help you navigate complex regulations, from design to disposal, ensuring your products are safe, effective, and ready for international markets.

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Who Needs ISO 13485 Certification?

This certification is a mandatory requirement for almost any organization involved in the lifecycle of a medical device. We support clients across the UAE, KSA, Australia, and New Zealand to meet local authority requirements (such as SFDA, MOHAP, and TGA), specifically in:

Medical Device Manufacturers
Distributors & Importers
Raw Material & Component Suppliers
Installation & Servicing Providers
Software for Medical Devices (SaMD)

Key Benefits of ISO 13485 Certification?

1
Global Market Access
Unlock international markets. ISO 13485 is often the first step to obtaining CE Marking (Europe) or FDA clearance, and is required by regulators in the GCC and Australia.
2
Regulatory Compliance
Ensure full alignment with legal requirements, helping you navigate the complex landscape of medical device regulations without fear of non-compliance.
3
Enhanced Product Safety
Implement robust risk management processes throughout the product lifecycle to identify and control risks, ensuring maximum patient safety.
4
Process Efficiency
Streamline your design, manufacturing, and distribution processes to reduce errors, waste, and recalls, leading to cost-effective operations.
5
Supply Chain Confidence
Prove to manufacturers and large healthcare providers that you are a reliable, quality-focused partner capable of meeting strict medical standards.
6
Brand Reputation
Demonstrate your commitment to quality and safety to patients, doctors, and stakeholders, building lasting trust in your brand.

Fast-Track Your ISO 13485 Medical Certification

About Us

MFT Global Consultancy transforms business potential into certified success. Serving the GCC and Oceania, we provide world-class training and strategic consulting in Medical, Food Safety, IT, and QHSE management systems.

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