Achieve Regulatory Compliance and Ensure Product Safety for Medical Devices

For manufacturers and distributors of medical devices, a systematic approach to quality is not just good practice—it is a stringent regulatory requirement. ISO 13485:2016 is the internationally recognized standard for Quality Management Systems specific to the medical device industry. It provides a comprehensive framework to ensure the consistent design, production, installation, and delivery of safe and effective medical devices. Intermax Consultancy delivers specialized expertise to guide your organization through the complexities of ISO 13485 implementation, supporting your path to certification and regulatory market access in Saudi Arabia, the GCC, and globally.

What is ISO 13485:2016?

ISO 13485:2016 specifies requirements for a Quality Management System where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The standard has a strong emphasis on risk management and regulatory compliance throughout the device lifecycle. It is harmonized with various regulatory frameworks, making it a critical foundation for market approval in regions like the European Union, GCC countries, and beyond.

Key Benefits of Implementing ISO 13485:2016

Global Regulatory Access: Establish a QMS that forms the core of regulatory submissions to bodies like the Saudi FDA (SFDA), UAE Ministry of Health, European Notified Bodies, and other international regulators.

Enhanced Patient Safety: Systematically manage risk in design and production, directly contributing to the safety and performance of medical devices.

Streamlined Processes and Reduced Errors: Implement controlled processes for design, production, and supplier management, leading to greater efficiency and fewer non-conformities.

Demonstrated Commitment to Quality: Provide documented evidence of your quality commitment to customers, regulators, and procurement officers, strengthening your market position.

Improved Traceability: Maintain rigorous documentation and traceability procedures, which are essential for effective recalls, field actions, and post-market surveillance.

Foundation for Other Standards: Create a compliant base for meeting additional requirements, such as the EU Medical Device Regulation (MDR) or FDA 21 CFR Part 820.

Our ISO 13485:2016 Consulting Methodology

We understand the technical and regulatory nuances of the medical device sector and tailor our implementation process accordingly.

1. Gap Analysis & Regulatory Pathway Review
We conduct a detailed assessment of your existing QMS against ISO 13485:2016 and identify applicable regulatory requirements for your target markets in the GCC and internationally.

2. System Development & Documentation
Our consultants develop the required quality manual, procedures, and specific documentation for critical processes like design controls, risk management (ISO 14971), sterile barrier systems, and post-market surveillance.

3. Risk Management Integration
We provide specific guidance on establishing and maintaining a risk management process in line with ISO 14971, integrated throughout your QMS.

4. Implementation & Internal Audit
We support the practical application of procedures and train your internal auditors to conduct effective audits of the medical device QMS, including supplier audits.

5. Management Review & Corrective Action
We facilitate the management review process with a focus on regulatory compliance and ensure a robust CAPA (Corrective and Preventive Action) system is operational.

6. Certification & Regulatory Audit Preparation
We prepare your organization for the certification audit with an accredited body and can assist in readiness for subsequent regulatory audits by authorities.

Our Certification Partnership

To ensure your certificate is recognized by regulators and global supply chains, Intermax Consultancy works with accredited certification bodies. Our partners hold UAF (UAE Accreditation Forum) and IAF (International Accreditation Forum) accreditation. This ensures your ISO 13485:2016 certification carries the necessary credibility for market access in Saudi Arabia, across the GCC, and in key markets like Europe and North America.

Why Select Intermax Consultancy for ISO 13485 Certification?

• Medical Device Sector Expertise: Our consultants possess direct experience with the regulatory and quality challenges unique to medical device companies.

• Regional Regulatory Insight: We provide knowledge of the specific requirements from the SFDA, GCC Central Committee, and other regional health authorities.

• Integrated Risk Management: We ensure your QMS fully incorporates the risk-based thinking required by ISO 13485 and ISO 14971.

• Practical Implementation: We focus on building a compliant system that improves real-world operations, not just creating documentation.

• Accredited Certification Pathway: Our partnership with UAF & IAF accredited bodies delivers a certification that supports your regulatory strategy.

Ready to build a compliant QMS for your medical devices and access global markets?

Contact Intermax Consultancy to discuss your ISO 13485:2016 project. Our specialized team is ready to support your medical device organization in Saudi Arabia, the GCC, India, and beyond.