Tag Archives: Medical Device PLM

Amazing PLM Governance

In this blog series, I provide insights as to why PLM has true potential to be so transformational for life sciences companies, but many aren’t getting there. We have come a long way – we have developed a defensible strategy, picked technology, and developed a change campaign. Now we need effective governance models in place to help mitigate risk, remove obstacles and ...

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Lifting the Lid on UDI’s Pandora’s Box

While working to comply with the rule, manufacturers have realized that the problem to be solved is multi-faceted and interconnected. It’s like the ancient Greek myth of Pandora opening the box releasing the not-so-pleasant things into the world. Although kinder to the industry than originally anticipated, the FDA’s UDI ruling is more complicated than just a labeling change, making implementation a challenge.

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