Why Bermondsey?
At Bermondsey Electronics we prioritise the safety of patients and operators above all else. In the development of medical devices, ensuring the highest standards of safety and quality control is paramount.
Our team is dedicated to adhering to the stringent regulations set forth by both the EU and US governing bodies.
From initial concept to final implementation, every step of our development process is carefully monitored and validated to mitigate risks and ensure compliance.
We utilise state-of-the-art technology and best practices to conduct thorough quality control checks, including rigorous testing and validation procedures.
Delivering secure data transfer for a medical treatment device
This customer required communication with their device in the field to validate their business model. There was a competing requirement to have as small a cybersecurity attack surface as possible, due to stringent new security requirements. The interface was challenging.
Medical Treatment Device
We implemented QR code scanning end to end to facilitate the business model. This made the attack surface as small as possible and prevents malicious reprogramming in the field. We used secure cryptography to ensure the data remains secure in transit. We can verify algorithm performance on the desktop and in challenging lighting conditions. We optimised the code to keep scan times low and accuracy high. Our efforts enabled the device to communicate its data securely.
For your project, this signifies a seamless integration with your QMS, ensuring adaptability in development strategies aligned with your requirements. Our team brings expertise in IEC 62304 compliance and alignment with ISO 13485, establishing clear project history through technical and project practices.
Our test plan for embedded medical device software includes strategies for comprehensive testing, identification of test cases and rare edge cases, execution procedures, defect management, and validation. It ensures regulatory compliance, risk mitigation, and stakeholder approval before release, safeguarding safety and reliability.
Medical device firmware is typically coded in languages like C, C++, or Python, but we cover the full tech stack utilising GPUs, MCUs, CPUs, FPGAs, and ASICs to optimise performance and efficiency. Each component is carefully selected and integrated to meet the device’s specific requirements and performance standards.
You receive fully developed and tested firmware that meets your device specifications, documentation covering design, implementation, testing and ongoing support for maintenance and updates as agreed in the project plan.
Presenting muscle injury data in a usable format
Our customer wanted to filter muscle injury data collected from the body. We wrote filters to present the data inside the fitness app. This offloads the processing from the insecure domain (an app, easily reverse engineered) to the secure domain (the customer product, protected by ARM secure boot technology). Presenting the data in a usable format required a lot of maths to a tight deadline.
Muscle injury data
We leveraged Zephyr OS to bring up the platform quickly. We had Bluetooth running in under two weeks. We used our in house testing and development tools to measure performance. Zephyr offers both secure boot and secure OTA update. We leveraged both. We added a module to take advantage of ARM’s optimised assembly routines for the maths. We delivered a verified prototype in under 6 weeks.
Don’t take our word for it, these are kind words from our customers
If you have questions about how we can help your business please complete the form below and we will be in touch shortly.
Alternatively, please call us on +44 (0)208 0650 162
Email : [email protected]
Bermondsey Electronics Ltd. is registered in
England and Wales. Registered number: 10524932
VAT Number: 259290869 Registered ofice: Unit
B.505, The Biscuit Factory, 100 Drummond Road,
London SE16 4DG, United Kingdom
© Bermondsey Electronics Ltd 2017-2023
FREE 30 Minute Consultation
Do you have a product under development that must function exactly as intended and exhibit high reliability in the field?
If so, we can help.