Developing medical devices based on the Raspberry Pi (CE certification)

A customer approached me about wanting to develop a medical device based on the Raspberry Pi. They have two stipulations:

• This should be a Class 1 medical device
• The device should connect to the Internet
• It is for the European market

I have investigated the available resources and suggestions with several partners, and am collecting their feedback on this page, for the reference of anyone who is exploring integrating a Raspberry Pi in their application.

Raspberry Pi

Raspberry Pi themselves state that their products should not be used in safety-critical applications, including life-support systems, nuclear reactors etc:

“HIGH RISK ACTIVITIES. Raspberry Pi products are not designed, manufactured or intended for use in hazardous environments requiring fail safe performance, such as in the operation of nuclear facilities, aircraft navigation or communication systems, air traffic control, weapons systems or safety-critical applications (including life support systems and other medical devices), in which the failure of the products could lead directly to death, personal injury or severe physical or environmental damage (“High Risk Activities”). RPL specifically disclaims any express or implied warranty of fitness for High Risk Activities and accepts no liability for use or inclusions of Raspberry Pi products in High Risk Activities.”

Raspberry Pi disclaimer in their datasheets

Note, that it is formulated as “where the failure of the products could lead directly to death, personal injury”. When developing a medical device, the designers have a possibility to implement failsafes in other forms, which the Raspberry Pi could not override – for example, physical limitations of flow rates, secondary control systems which monitor the Raspberry Pi and it’s correct operation, and take over in a limited failsafe mode, etc.

It is up to the designers, and required by the norms in the CE certification, to follow a risk management process (ISO 14971 – Medical devices — Application of risk management to medical devices) for the design.

Part of this risk management process is to identify potential risks which could occur in the intended or unintended use of the device, to assess the risk, and to devise technical and other provisions (e.g. warnings in the instruction manual) which reduce the risk to tolerable levels.

Therefore, the word directly as quoted above is very important – if the device is designed in a fashion, in which a potential malfunction of the Raspberry Pi (or any other SBC / industrial computer for that matter) is caught by other safety measures, it may be used in medical applications.

Thus, there are several customers of Raspberry Pi using it for medical applications. It is a very solid, and beautifully engineered hardware and software platform, with millions of devices in the field. Furthermore, they have had several iterations of their hardware, in which they were able to fix bugs and problems, and refine the hardware with every iteration.

Raspberry Pi applications team

Raspberry Pi has an applications team (applications [at] raspberrypi.com) which can give general advice, whether the Raspberry Pi is suitable for a particular application / which model to use / if you run into technical issues.

However, to me they said: “We do not certify as medical devices.”, and asked me to speak to UL or a similar provider for further advice.

I currently do not think there is a point to asking them general questions such as “is the Raspberry Pi suitable for integration into my medical device”? They might, however, answer technical questions about compatibility with certain extension modules, power usage, temperature profiles etc.

UL

UL is the certifier which Raspberry Pi uses for their certifications. We have some experience with them, having certified a Raspberry Pi 4 based product with a built-in color touch display with them, as well.

They are not able to give you recommendations which product to use for your medical device, as they are a certifier themselves.

They can certify medical devices, and they have a team in Germany for that.

However, they can offer a pre-development evaluation of your design concept. (Technical pre-assessment) In this evaluation, they will let you know if the design has a chance of getting through the certification. Usually this would be about one day of UL’s consulting services, and thus cost 4000 € net. This is excluding travel costs for the engineer, if they have to come to you.

Regular Services

German-based Regular Services offers consulting to support you with the development around your medical device. I have spoken to one of their consultants. He pointed out some important things to me:

• changes and updates should be avoided as the device is certified in a certain state of development (which clashes with Internet functionality, which requires regular security updates)
• it is important that the Raspberry Pi is available in the same configuration during the lifecycle of your medical product (see below)
• connecting your medical device to the Internet – this is something which many companies developing medical devices are looking at, due to advantages (e.g. technician can do remote diagnostics) – however it has many challenges associated with it (additional safety precautions are required so this functionality can’t be abused). Regular Services has a consultant who can consult about this.

They offer a free initial session to discuss whether their services are a match for your need. They can also support you with the form of the required technical documentation.

Their hourly rates are about 190 € net – however, for a project they would give you a project cost estimate, as there are other project costs, as well.

Further considerations

long-term availability

For your medical device, long-term availability of the underlying hardware is key. Once certified, you want to manufacture exactly what was certified. Every medical device manufacturer thus has to monitor change notices, and also only design-in boards with an appropriate long-term availability, which will support the lifecycle of their product.

One (expensive) solution to this is to stock the critical components for the entire lifecycle of your medical product. A better solution is to look for vendor guarantees on long-term availability.

Raspberry Pi offers longterm availability and guaranteed availability times on their products. I have compiled a list of Raspberry Pi long-term availabilities here. (The Raspberry Pi 4, for example, will be available until at least January 2031). Note that Raspberry Pi will continue to manufacture the products beyond those dates, as long as it is commercially viable for them (e.g. the SoC is available, etc.)

24/7 operations

Consider whether your device will need to operate 24/7. Raspberry Pis, as mentioned, are very solidly engineered devices – my concern would mainly go out to microSD cards, and their wear- and tear under 24/7 operation. You can use different strategies to mitigate this, and possibly also use higher quality microSD cards (e.g. special industrial grade microSD cards – we can support you here through our partner Cardwave). Another way to improve the performance and stability of your device would be to design-in Raspberry Pi Compute Module 4 (long-term available until at least January 2031 as well). You can talk to us to discuss whether a compute module might be a good solution for your project.

Product change notices

As a developer and manufacturer of medical devices, you are responsible for market vigilance. This includes problems experienced with similar products, and also changes to the underlying products.

Raspberry Pi supports you, and other industrial manufacturers, with PCNs (product change notices), which outline which changes were necessary on devices. This is due to some components which are used on the Raspberry Pi becoming obsolete, or also optimisations for the manufacturing process.

These PCNs are available in the PIP (product information portal).

Tinkerboards

A look at a competitor of Raspberry Pi in the market: ASUS manufactures Tinkerboards, and has confirmed to me that they are used in general purpose medical applications. For example such as gateways, complementary devices to the main control unit, or signage displays. There are no Tinkerboards currently in high-risk environments, like operating theatres.

Some of the models also have built-in eMMC (with Raspberry Pi, you need to design a baseboard with the CM4 – or purchase a baseboard which supports the eMMC, there is no eMMC version of a Raspberry Pi SBC currently). This could potentially drive down your development cost, if you are able to incorporate a Tinkerboard SBC instead of a Raspberry Pi CM4.

Some tinker board models have been designed for 24/7 usage.

ASUS has a dedicated team for medical products in Taiwan.

So, the Tinkerboard might be a viable choice for you, and an interesting alternative to consider to the Raspberry Pi. As we focus on the Raspberry Pi, we cannot advise you on the Tinkerboard beyond this.

Other competitors

There are other competitors, for example Banana Pi, Orange Pi, etc. I advise you against these, as these are much smaller organizations than Raspberry Pi and ASUS.

It might therefore be riskier to develop medical devices based on these products, and possibly not worth the potential cost savings of the underlying hardware.

Consulting & support with your Raspberry Pi and Artificial Intelligence hardware needs

We are a European company, based in Leipzig, Germany, and can support you in all your requirements around Raspberry Pi and artificial intelligence hardware. We have an in-house team of software engineers, and pride ourselves on our deep technical experience.

In cases where we do not have the required expertise in-house, we have a network of partners, to which we can refer you.

Get in touch with us today to discuss your project with us.

FAQ

Can I develop a medical device based on the Raspberry Pi?

Yes, you can develop a medical device based on the Raspberry Pi, if you design your device in such a way that the whole system will not fail and lead to injury of the patient or other parties in case the Raspberry Pi fails.

Is the Raspberry Pi a good choice for building a medical device on?

When designing in a computer into your medical device, you will be faced with similar challenges, irrespective of which computer hardware base you build upon. Raspberry Pi is one of the most solid, well-engineered, and in-depth tested computer platforms on the market.

Raspberry Pi has different product lines. The CM4 is an industrialized version of the Raspberry Pi SBC, and may be better suited to your medical application. We recommend to evaluate the requirements of your particular medical application with the performance characteristics of the Raspberry Pi platform to make an informed decision. Contact us to discuss your project, we can support you in making a good choice.