Medical Wearables Testing and Certification

As medical wearables become smarter, smaller, and more connected, so too do the challenges of bringing them to market safely and in full regulatory compliance. Intertek offers a complete suite of medical wearables testing and certification services designed to help you navigate those challenges with confidence. From electrical safety and EMC testing to wireless compliance, cybersecurity, and AI validation, we support every stage of the product lifecycle, so you can launch faster, safer, and with global market access in mind.

Whether you're developing a continuous glucose monitor, a wireless ECG, or an AI-powered diagnostic patch, Intertek’s technical depth and global reach help ensure your wearable medical device meets the requirements of today’s regulators and the expectations of tomorrow’s users.

Medical Wearables: Innovation Meets Complexity

Medical wearables are body-worn devices that monitor, analyze, and transmit health data in real-time. They are used outside of clinical settings, often in daily life, which introduces risks and use conditions not encountered by traditional stationary devices. These wearables, ranging from biosensor patches and smartwatches to remote monitoring systems and diagnostic headsets, must meet a range of standards that address everything from electrical safety and skin contact to cybersecurity and radio frequency emissions.

Their close interaction with the human body, continuous data collection, and reliance on wireless communication make medical wearables some of the most highly scrutinized devices on the market today. Intertek ensures your device is tested and certified to meet every expectation.

A Comprehensive Testing Approach

Intertek evaluates medical wearables to the industry’s most recognized safety and performance standards. Electrical safety is assessed using IEC 60601-1, while wearables designed for home use are tested under IEC 60601-1-11. Devices with embedded multimedia features may also be subject to IEC 62368-1, particularly if audio or video elements are included.

For electromagnetic compatibility, we test to IEC 60601-1-2 to verify emissions and immunity in the presence of RF interference, a vital step for connected devices used in uncontrolled environments. When wireless connectivity is involved, we conduct region-specific testing under FCC, ETSI, MIC, and other regulatory frameworks. This includes evaluations for Bluetooth, Wi-Fi, LTE, and 5G, along with Over-the-Air performance, coexistence testing, and protocol validation.

Specific Absorption Rate (SAR) testing is performed on devices worn close to the body to confirm that radio frequency energy levels remain within safe limits. We simulate real-use scenarios using tissue-equivalent phantoms, ensuring that your device meets FCC, ICNIRP, and other global SAR requirements.

Biocompatibility is another essential area of evaluation. Intertek conducts ISO 10993 testing to assess the safety of materials that contact skin, helping reduce the risk of irritation, sensitization, or cytotoxic reactions. At the same time, our performance testing validates sensor accuracy, battery life, wireless strength, and operational reliability—both under normal conditions and during environmental stress. Drop resistance, moisture ingress, sweat exposure, and vibration testing are also available to simulate real-world usage.

Cybersecurity for Medical Wearables

In today’s connected healthcare environment, cybersecurity is no longer optional, it is a core regulatory requirement. Intertek’s cybersecurity testing services help ensure that your device protects patient data and resists unauthorized access or disruption. We align with standards such as IEC 81001-5-1, UL 2900, and FDA guidance, evaluating everything from secure coding and threat modeling to authentication, encryption, and post-market patch management.

We also help manufacturers develop and maintain a Software Bill of Materials (SBOM), manage vulnerability disclosure programs, and conduct penetration testing to simulate real-world cyber threats. These activities ensure that your wearable medical device complies with both international regulations and modern expectations for digital safety.

Supporting AI-Enabled Wearables

Many next-generation medical wearables now include artificial intelligence or machine learning algorithms designed to detect patterns, offer insights, or support clinical decision-making. Intertek offers specialized support for these AI-enabled systems. Our AI² program helps evaluate algorithmic bias, generalizability, transparency, and robustness under regulatory guidance from the FDA, EU MDR, and other global authorities.

We assess your training data sets, change control procedures, and model validation strategies to ensure consistent, clinically reliable performance. Whether your algorithm adapts over time or operates as a fixed model, we help you document its safety, effectiveness, and compliance.

Interoperability and Software Validation

Today’s wearable medical devices rarely operate in isolation. Most connect to mobile apps, cloud platforms, or electronic health records, and they must do so reliably. Interoperability testing is essential to confirm accurate, secure communication between systems. We validate your device’s ability to exchange data using protocols like HL7, FHIR, and Bluetooth Health Device Profile, reducing the risk of data loss or integration failure in clinical workflows.

We also support software validation under IEC 62304 and help manage software updates over the air (OTA), ensuring continued compliance throughout the device’s lifecycle.

Global Regulatory Approvals and Market Access

Whether you're targeting FDA clearance in the U.S., CE marking under the EU Medical Device Regulation, or approvals in Canada, Japan, China, or Australia, Intertek provides the documentation and regulatory support needed to streamline your path. We help you prepare your technical file or design dossier with safety, EMC, software, biocompatibility, and risk management documentation, all aligned with the requirements of each region.

Our support includes 510(k) preparation, De Novo requests, and Premarket Approval (PMA) guidance in the United States, as well as UKCA submissions in the United Kingdom. Even if your device includes pre-certified modules, we ensure the integrated product meets end-device testing requirements.

Why Manufacturers Choose Intertek

Intertek offers more than just testing, we offer a strategic partnership. Our customers benefit from decades of experience, global regulatory insight, and a fully integrated approach. All major services are provided under one roof, reducing coordination issues and expediting project timelines. We tailor each test plan to your product’s features and intended use, whether it's used at home, on the move, or in clinical environments.

With our network of laboratories and experts around the world, we support both early-stage startups and global medtech companies in navigating today’s complex compliance landscape.

Your Wearable. Our Expertise.

Intertek empowers innovation in healthcare by helping manufacturers bring wearable medical devices to market safely and confidently. Whether you’re creating a fitness-adjacent wellness device or a regulated AI diagnostic system, our team can guide your product through safety, performance, cybersecurity, and regulatory testing every step of the way.

If you’re ready to simplify your journey from design to certification and gain global access with a trusted name in compliance, Intertek is here to help.