Safety and compliance challenges for medical devices


Sep 07, 2022

Compliance challenges can come from the user interface of your medical device. The display often has a projected-capacitive touchscreen, capacitive sliders/buttons, or a keypad, and these design specifications can present some specific regulatory tests.

Let’s Talk About EMC and ESD

  • Electromagnetic compatibility (EMC) – the user causes disturbance by touching the touchscreen, and this must be detected and decoded, whereas the system must also be immune to disturbances such as noise coupled through any attached cables
  • Electrostatic discharge (ESD) - immunity must be assured and, where there is touch, user safety demands extra consideration
EMC and ESD must be taken into account for medical devices

Understanding Geographical Nuances

As user-interface design experts, we have acquired a broad and deep understanding of applicable regulations and test specifications, how they impact on design decisions, and how the regulations vary from territory to territory. Have you considered designing for the market you are in and the ones you may want to enter and what their regulatory requirements might be?

  • EU
  • North America
  • Asia
Design for Compliance

The Benefits of Design for Compliance (DFC)

DFC tends to offer the most economical and time-efficient route to market. The peace of mind that your product has been designed to comply with the applicable regulations is priceless. Imagine the cost of discovering at a late stage that your product will not achieve the required level of conducted noise immunity when tested in accordance with IEC 61000-4-6!  This could involve extra time and engineering effort to re-optimise device firmware and go through testing again. At worst, it may call for even more expensive and time-consuming design changes.

Overcoming an EMC Failure

Failing an EMC test doesn’t need to end your medical devices design journey. Post failure, a typical escalation path that we can walk you down to overcome a failure and to pass the conducted noise immunity tests encompasses the following measures:

However, we also appreciate, that it can be a Catch 22 scenario, in that sometimes you won’t know whether your medical device will pass or fail until you’ve gone through the actual tests. But again, even if you find yourself in this situation with a ‘‘failure’’ at the end of this process, we can help you to quickly identify the fastest and most economical approach that will get your product on the right side of the regulations.

It is worth considering though, that the later you turn your attention to compliance, the more difficult and expensive it can be to make any changes needed to achieve the certifications you need. Versus the earlier that you get in touch with us, the more likely we can deliver a suitable embedded and LCD display solution that will meet your medical device needs and your allocated go-to-market budget.

Want to discuss your Medical design requirements? Get in touch!