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 Ophthalmic Injectables' Regulatory Complexity
Intravitreal injectables face some of the strictest regulatory scrutiny in drug development. Learn what sponsors need to know about EU GMP Annex 1, USP standards, and container closure integrity to stay compliant.
Medbio combines tooling, molding, automation, assembly, packaging, and quality support to help medical manufacturers reduce complexity, manage risk, and move programs efficiently toward production.
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.
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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