FEATURED EDITORIAL
Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.
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Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.
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Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
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Post-market HF are more than a quality metric, they help teams diagnose issues, guide fixes, and improve real-world usability of drug-device products beyond validation.
INDUSTRY INSIGHTS
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Designing Contactless Patient Monitoring For The Real World
Contactless patient monitoring works best when designed for real‑world needs. Aligning sensors, accuracy, algorithms, and privacy delivers insight where monitoring falls short.
NAM adoption is constrained by inconsistent cell sourcing, limited standardization, and regulatory uncertainty — barriers that must be addressed to enable reproducible evidence and regulatory trust.
Precision is a must with optical micromolding. Accumold’s twenty plus years of experience with ultra precision micro-molding lends itself well to this market. Extremely tight requirements with lens to lens centricity in 125 micron fiber arrays is an everyday process at Accumold
Precise timing has confined effective neurorehab to clinics. Wearable, semi‑autonomous neurostimulation uses muscle signals to sync stimulation with effort, enabling recovery beyond supervised care.
Choosing an R&D partner requires more than reviewing past successes. Evaluating judgment, flexibility, and risk management reveals how a partner will perform when development gets complex — and when it matters most.
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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