Whitepaper: Transitioning to Agile

In biomanufacturing, biotechnology, manufacturing, medical device, medtech, operational excellence by GenerisLeave a Comment

Safety-critical industries face many challenges including stringent regulations and requirements, and increased pressure to speed time to market while improving product quality. As a result, it is often difficult for organizations to move away from traditional development processes and integrate agile methodologies. Seapine Software has generated the whitepaper below to help medical device manufacturers overcome these barriers and successfully transition to agile in a safety-critical environment. To hear more from Seapine Software, join the discussion at the American Medical Device Summit taking place this October!

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eBook: Traceability Optimization for Medical Device Developers

In healthcare technology, manufacturing, medical device, medtech, product development, traceability by GenerisLeave a Comment

Regulatory bodies such as the FDA require medical device manufacturers to document and track huge amounts of information to ensure device safety and demonstrate that safety in the event of an audit. Given the volume and complexity of information to be tracked, many medical device developers struggle with traceability. We sat down with Seapine Software to better understand the challenges medical device developers face, and how they can be overcome. Check out the Traceability Optimization eBook below! eBook, Traceability Optimization for Medical Device Developers  

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