FEATURED EDITORIAL
A Much-Improved Approach For Understanding And Managing Safety Risks
Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.
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Let's take a closer look at the scientific principles, technological progress, and translational hurdles defining the present state of microneedle research.
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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.
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.
Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs and what it takes to stay compliant.
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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