;   Medical Translation Insight: What's the fuss about IEC 62304? - ForeignExchange Translations

What's the fuss about IEC 62304?

What's the fuss about IEC 62304?Medical translators are well aware of the importance of safety for medical device. In the past, emphasis has generally been on the hardware and little thought was given to the software that is an increasingly crucial part of these devices.

That has changed, thanks to two events: the updated Medical Device Directive in Europe and IEC 62304 [PDF link].

While most of us are by now well acquainted with the revised MDD, clients mentioning and asking about IEC 62304 is still new for many medical translation service providers.

The June issue of European Medical Device Technology featured a nice overview of IEC 62304. Developing Medical Device Software to IEC 62304 shows that for medical device manufacturers, IEC 62304 is a useful complement to ISO 13485 and ISO 14971.

It is interesting to note that it is the device manufacturer's responsibility to handle the safety classification of the software. This classification occurs on three levels, based on risk management and the level of injuries that the software could cause:

  1. No injury or damage to health possible
  2. Non-serious injury possible
  3. Death or serious injury possible
Compliance with IEC 62304 requires a quality management system (e.g., ISO 13485) and risk management (ISO 14971) - a low bar for any medical device company. Even better: Device companies do not have to reinvent processes for developing medical device software - ensuring that its practices are compliant with the standard is sufficient.

As we mentioned a year ago, IEC 62304 has enjoyed broad acceptance among medical device manufacturers. Now it's up to medical translation suppliers to catch up!

[Tip of the hat to Bob on Medical Device Software]

Want to know more about IEC 62304? Delve into the following:

ForeignExchange's QMS is certified to ISO 9001, ISO 13485, EN 15038 and compliant with ISO 14971. For your next medical translation and software localization assignment, request a detailed proposal from ForeignExchange.


  1. Amelia said...
    It's really essential to keep strict controls in medical translations as a poor translation may result in serious damages and even death.

    As professional translators, today we have and should think of machine translation for our daily work, especially with post-edition.

    What do you think about this in this sensible field?

    We have some posts here:


    Thanks for your input,

    amaxson said...
    @Amelia: We agree. Medical and pharmaceutical translations require great attention to detail, and a high standard of quality. ForeignExchange is proud to have a system of measurable quality, MetriQ.

    For more reading about Machine Translation and how it might fit into daily work for professional translators, agencies and clients alike, check out our recent blogs regarding this topic:

    There are lots of great comments from both sides of this argument contained in these articles! Happy reading!

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