Testing of medical devices poses a considerable challenge in terms of cost, effort and time. This is a critical and challenging phase of the product development lifecycle; especially when we have to meet the stringent guidelines imposed by medical device regulations such as IEC 62304 and ISO 14971.
Manual testing can be very expensive and time-consuming, contributing to as high as 60% of the development cost. This is where automation steps in. The benefits of cost saving through automation significantly outweigh the initial investment.
However, there are important considerations when it comes to automation of testing and other activities after the code is checked-in. Here are a few:
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