Medical device development is increasingly reliant on software to enhance the functionality and maintenance of medical products. In the context of medical device development, software complexity equals risk. Therefore, increasingly stringent regulations and industry standards have been devised to stipulate thesafety, reliability and quality requirements. This article from Intland outlines how to achieve and prove compliance with several standards such as IEC 62304, ISO 14971 and IEC 60601. Read More

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