FEATURED EDITORIAL
Minding The Gap: Submission Strategies For Combined Use Combination Products
For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.
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A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.
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Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.
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Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
INDUSTRY INSIGHTS
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Visual Work Instructions: Your Key To Improving Operator Performance
Paper SOPs weren’t built for fast-changing production environments. Visual work instructions bring guidance to the point of use with visuals and real-time updates to reduce errors and improve training.
Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.
Active implants are pushing past battery limits as energy‑harvesting taps motion, heat, and biochemical signals. Hybrid systems could shrink devices and enable longer‑lasting, self‑powered implants.
Growing patient demand and limited clinical capacity are straining modern care. Assistive technologies help standardize procedures, reduce variability, and enable consistent, high‑quality outcomes.
As regulations continue to shift, staying current with the latest expectations is essential for maintaining compliance and ensuring patient safety.
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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