Medical Robots Testing and Certification

Intertek provides comprehensive testing, certification, and quality assurance solutions for medical robots and robotic medical devices, helping manufacturers meet global regulatory requirements and bring advanced robotics to market with confidence.

As a global leader with unmatched expertise and accreditations in medical device testing and certification, we support developers of robotic assisted surgery systems, rehabilitation exoskeletons, AI-enabled robotic platforms, and more by aligning safety, performance, and regulatory strategies with the most current standards: IEC 80601-2-77, IEC 80601-2-78, IEC 60601, and ISO 14971.

The Expanding Role of Medical Robotics in Healthcare

Today’s medical robotics technologies are reshaping the way healthcare is delivered. These systems offer greater precision, consistency, and scalability across a wide range of clinical and support functions, enhancing patient outcomes and operational efficiency.

From the operating room to the rehabilitation center and the patient’s home, medical robots are being deployed to:

• Improve surgical precision and reduce recovery time through advanced motion control and haptic feedback systems
• Assist with repetitive or strenuous physical therapy through responsive wearable robotics
• Automate routine clinical tasks and deliver personalized care using AI-driven perception, learning, and decision-making capabilities

With the integration of artificial intelligence, machine learning, and connectivity, today’s medical robotic devices are intelligent, adaptive, and increasingly autonomous, requiring higher levels of quality assurance, functional safety, and cybersecurity.

Medical Robotics Compliance: Global Standards You Need to Know

To ensure safe performance and market acceptance, medical robots must comply with a growing set of international standards:

• IEC 60601 series – General requirements for medical electrical equipment
• IEC 80601-2-77 – Particular requirements for robotically assisted surgical equipment
• IEC 80601-2-78 – Particular requirements for rehabilitation and assistive robots
• ISO 14971 – Risk management for medical devices
• IEC 62304 – Medical device software lifecycle processes
• IEC 81001-5-1 – Cybersecurity for health software and health IT systems

Our experts help manufacturers navigate these and other regulatory expectations, reducing the risk of costly delays and market access challenges.

Cybersecurity in Medical Robotics

Modern medical robotic devices are increasingly reliant on software, connectivity, and data integration. This digital evolution introduces new vulnerabilities and risk profiles, making cybersecurity a critical aspect of regulatory compliance and patient safety. Intertek provides comprehensive support to address these challenges, offering services such as cybersecurity risk assessments, threat modeling, and penetration testing specifically tailored to medical robotics.

We help manufacturers align with key standards and regulatory expectations. Our approach ensures that your robotic systems are not only compliant with regulations, but also protected against cyber threats, resilient to disruptions, and trusted by users in clinical settings.

AI-Enabled Robots and Risk-Based Assurance

AI integration in medical robots requires a new level of diligence. Whether you're deploying machine learning algorithms, real-time decision systems, or autonomous functionality, we help you address:

• Safety and ethical use of AI
• Transparency and explainability
• Compliance with global AI governance expectations

Intertek AI² offers consulting, training, and validation services to support AI-enabled robotic systems across their entire lifecycle.

Interface and Interconnect Conditions

The evaluation of medical robots requires consideration of interface and interconnect conditions with other supporting equipment, including endoscopic, positioning systems, HF surgical equipment, lasers, motorized cutting and drilling tools, suction equipment, patient monitoring, ultrasound, or other types of equipment. This supporting equipment may be integrated into the robotic system or can be used as standalone support equipment. In either case, the robotic evaluation must consider this when integrated with other medical systems. Intertek has the experience and accreditation to address all types of medical support equipment that may interact with the robotic system.

Your Strategic Partner for Medical Robots Quality Assurance

Intertek provides complete medical robots testing and certification services, including:

• Risk management evaluations aligned with ISO 14971
• Testing to IEC 60601, IEC 80601-2-77, and IEC 80601-2-78
• EMC, wireless, and environmental testing
• Functional safety and laser safety evaluations
• Software and usability assessments
• Global Market Access support

Our global labs and regulatory experts ensure your devices meet both technical and market-specific requirements, accelerating your product launch and ensuring post-market success.

Let us help you bring smarter, safer, more effective medical robots to market. Partner with Intertek to deliver innovation backed by confidence, compliance, and Total Quality Assurance.