FEATURED EDITORIAL
The Standard You Stopped Reading In 1996 Just Rewrote Your 2030 Audit
On Sept. 16, 2026, ISO published the sixth edition of ISO 9001. Most medical device professionals shrugged, feeling that we live in ISO 13485. That shrug is a mistake.
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A recent survey conducted with BioPhorum members revealed that the most critical aspect of digital healthcare for drug delivery devices. Let's take a closer look.
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Where can digital technologies can solve real problems for patients, healthcare providers, and industry, while avoiding unnecessary complexity? Here's where the strongest value propositions currently sit.
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P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.
INDUSTRY INSIGHTS
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Advance Fluidic And Optical Systems With The Right Partnership
Juggling separate fluidics and optics suppliers slows development. See how one engineering partner can streamline integration, improve accuracy, and speed scale-up.
Explore how OEMs optimize instrument performance with precision fluidics, optical technologies, and integrated subsystems that improve reliability and accelerate development.
Edge or notch filter? Learn how each blocks the laser line in Raman systems and which delivers the low-shift reach, tunability, or Stokes/anti-Stokes coverage your application needs.
Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.
Removing the handoff between patient self-screening and enrollment changes what a fully virtual observational study can achieve, from conversion at peak intent to completion rates among participants.
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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