Meeting regulatory 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 and mobile applications.
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 and wireless testing through to full evaluation and certification to UL 2900. Our experience with cybersecurity 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 cybersecurity 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 device:
Security
Intertek offers a wide range of services including testing to ANSI/UL 2900-2-1, Cybersecurity Risk Management Workshops, Vulnerability Assessment and Penetration Testing for Medical Devices, and Continuous Vulnerability Monitoring.
UL2900: a globally recognized cybersecurity standard, since 2018 an adopted standard of the FDA, as well as other cybersecurity 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
Knowledge Center
- Cybersecurity Awareness Training Fact Sheet
- Common Criteria Certification Process Fact Sheet
- FIPS 140-3 Process and Service Offerings Fact Sheet
- 5G Technology Assurance Solution Fact Sheet
- Cyber Security Risk in a Mass Remote Working Environment Webinar
- Intertek Cyber Assured Fact Sheet
- Consumer Product Focused Cyber Security Test and Certification Program
- PCI PIN Transaction Security (PTS) Cyber Security Fact Sheet
- Cyber Security Assurance Overview
- ANSI/UL 2900 Cyber Security Assessments Fact Sheet
- Software Assurance Overview
- Network Certification Guides
- Guide to PTCRB Certification
- Guide to Verizon ODI Process
Upcoming Events
Cybersecurity Assurance Overview
Intertek provides tailor-made security solutions designed and executed based upon risk factors commonly associated with your specific product and industry.
