Compliance Solutions for Connected Medical Devices

The rise of connected technologies in healthcare is driving innovation but also introducing complex regulatory and compliance challenges. Medical device manufacturers face a growing array of requirements designed to ensure safety, security, and functionality in an increasingly interconnected world. Intertek offers expertise in addressing both established standards and emerging requirements for connected medical devices, helping manufacturers bring compliant, cutting-edge technologies to market.

From ensuring compliance to Cybersecurity requirements such as IEC 81001-5-1 or navigating emerging technologies like AI-Enabled and Machine Learning medical devices, Software as a Medical Device (SaMD), implantables and robotics, Intertek is equipped to guide manufacturers through today’s regulatory landscape. As standards evolve to address new challenges, our tailored services ensure your products meet both current and future demands.

Wireless coexistence is vital for medical devices to function reliably amid interference from other wireless technologies, ensuring patient safety, data integrity, and regulatory compliance. Intertek’s Wireless Coexistence Testing evaluates device performance under real-world conditions, adhering to standards like ANSI C63.27 and AAMI TIR69, and addressing risks from technologies such as Wi-Fi, Bluetooth, RFID, and 5G. By simulating professional environments with high-frequency surgical equipment and complex networks or home settings with smartphones and smart devices, we ensure your products meet EMC requirements and maintain critical functionality.

As regulations for connected technologies continue to evolve, Intertek remains at the forefront, offering manufacturers the tools, knowledge, and confidence to succeed in this dynamic market.  

Intertek's Connected Solutions for Medical Devices

Software as a Medical Device (SaMD)

Comprehensive solutions to help Software as a Medical Device (SaMD) developers navigate the intricate regulatory landscape, ensuring their products are both safe and effective.

AI Enabled Medical Devices

Intertek provides tailored solutions for Medical Devices that address AI data quality, algorithm transparency, and compliance with global regulatory frameworks.

Wireless Technology in Medical Devices

Intertek offers comprehensive Wireless Testing services for Medical Devices including performance, security and privacy solutions helping you to market faster.

Cybersecurity for Medical Devices and Healthcare Equipment

Meeting regulatory requirements for secured medical product, healthcare equipment and solutions.

Implantable Medical Devices Testing Solutions

Intertek can help Implantable Medical Devices such as Cochlear Implants, monitoring devices, pacemakers, etc comply to safety, EMC and product-specific standards

Unique Device Identification (UDI) Compliance Services

Leverage Intertek’s expertise in Unique Device Identification (UDI) Compliance solutions to navigate the complexities of UDI compliance and to ensure your medical devices are compliant, traceable, and safe.