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Final Rules Artificial Intelligence Manufacturers

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

Gardner Law on

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2023

Foley & Lardner LLP on

Agility and resiliency remain essential attributes for manufacturers in 2023. Manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the...more

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