Break down barriers to compliance

For medical device manufacturers of all kinds, regulatory compliance is a significant hurdle that must be cleared when bringing new products to market.

For diagnostics and instrumentation specialists, that challenge is further compounded by the complex, multidisciplinary nature of their product design.

Compliance hinges on scrutinizing and validating a comprehensive range of design and testing documentation, including design history files, device master records and requirements, change and project management reports. In a siloed working environment, with, say, design, systems and production teams using their own documentation processes, the need to trace, surface and share all the necessary documents can be cumbersome and extremely time-consuming.