FEATURED EDITORIAL
CSV Assumes The AI System Sits Still — It Doesn't.
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
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Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers and document owners are defined appropriately, approval can be streamlined.
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Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
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Mass consolidation is sweeping up small medtech organizations. Med device startups and early-stage companies that want to be part of this rebirth must develop strategies for taking advantage of the new ecosystem.
INDUSTRY INSIGHTS
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Don't Lose Sight Of Opthalmic Injectables' Regulatory Complexity
Evolving regulatory guidance surrounding intravitreal therapies is providing drug developers with greater clarity about expectations from components sourcing and production to final packaging.
As the intravitreal therapy market grows and applicable regulations evolve, continued compliance demands technological savvy and rigorous contamination control.
Micro insert molding enables smaller, more integrated medical devices—but reliable polymer-metal interfaces require precise insert handling, material selection, positional control, and validation.
Achieve continuous regulatory readiness by embedding ALCOA++ compliance directly into manufacturing workflows to eliminate paper-based documentation risks.
The future of NAMs depends on robust biology, standardized practices, and submission-ready evidence that demonstrates value and strengthens regulatory trust.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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