Cyber Security for Medical Devices and Healthcare Equipment

Meeting FDA requirements for secured medical product and solutions

Connectivity and the IoT is bringing huge advantages to medical devices. Both for individual patients, where real-time remote monitoring and diagnosis brings personalized medicine with minimal disruption to daily life, to society more broadly as medical Big Data collected from connected devices speeds the development of new medicines.

However, the associated risks are significant, from data privacy concerns about individuals’ most sensitive information being accessed through to fatal risks associated with compromised embedded devices.

Intertek’s services help clients launch products which harness the huge benefits of connectivity whilst mitigating the risks. Building on the many decades Intertek has spent working with global manufacturers to meet healthcare regulators’ requirements in markets around the world, with a focus on technical excellence and rapid service delivery, Intertek Connected World offers a range of services from basic penetration tests through to full evaluation and certification to UL2900. Our experience with cyber security on Medical Devices ranging from surgical robots to hospital monitoring equipment helps our clients eliminate security flaws, meet regulatory requirements and launch successful products.

Network level testing: in addition to product cyber security testing, Intertek has extensive experience help hospitals and other healthcare providers main a high level of network security. Learn more.

Intertek offers the complete range of testing, certification and assurance services to launch a successful connected medical devices:

Security

 
UL2900: a globally recognized cyber security standard, since 2018 an adopted standard of the FDA, as well as other cyber security standards are provided by Intertek. Learn more

Connectivity

 
Cellular network access: to give Medical Devices to greatest flexibility, many manufacturers are using cellular technologies such as NB IoT. This is particularly useful for products used outside a hospital environment. Learn more

Regulatory

 
Products containing radios (cellular or short range (ie Bluetooth), must undergo EMC testing, and if close to the body, as is typical with Medical Devices, SAR (Specific Absorption Rate) testing. Learn more

Performance & Interoperability

 
To achieve commercial success, on top of safety and security requirements, products must interact seamlessly, with a wide diversity of other connected devices, from tablets and cell phones home hubs. Intertek’s interoperability services ensure your product can thrive in the IoT ecosystem. Learn more

Other Services

 
Intertek offers a range of other services to meet the needs of market access for medical devices globally, from electrical safety, to extractables and leachables investigations. Learn more
 

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