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:
- No injury or damage to health possible
- Non-serious injury possible
- Death or serious injury possible
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:
- International standards and International standards and guidance that address guidance that address Medical Device Software Medical Device Software [PDF link] from the 11th annual GHTF conference
- FDA's Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
- Agile Software Development and IEC 62304:2006 - Medical Device Software Compliance
- Regulatory strategies for IEC 60601
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.