;   Medical Translation Insight: Risk-based software validation for medical devices - ForeignExchange Translations

Risk-based software validation for medical devices - medical translationIt isn't glamorous, and usually it isn't considered a core competency. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent.

Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look to new and improved ways to complete software development and handle software localization, medical device companies also need to be looking for new and improved ways to validate their software.

This being the medical device industry, there exist a variety of standards and different elements for risk-based software validation for medical devices:

ISO 13485 requires that companies establish documented procedures for the validation of the computer software used in production. The intended application of computer software in monitoring and measuring devices must be confirmed before initial use.

IEC 62304:2006 is the latest international standard for medical device software according to the software life cycle process model. Jointly developed by FDA and industry, the standard covers software development and maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, as well as software process management.

IEC 62304 has enjoyed broad acceptance. One of the reasons is that it addresses the special concerns of risk management that are unique to software development. These issues apply to production control software for medical devices as well as the device software itself.

UPDATE: See our article What's the fuss about ISO 62304? and our audio conference Agile Software Development and IEC 62304:2006 - Medical Device Software Compliance for more details on this topic.

ForeignExchange Translations provides specialized medical translation services to the world's leading pharmaceutical and medical device companies.


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