Devices are Getting Smarter, Making Materiovigilance Evolve Faster

By Dr. Padmalakshmi Jnaneshwar

According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. Within this gap, fragmented data and manual processes continue to slow response times and increase compliance risk, creating a disconnect between the promise of real-time safety monitoring and operational reality. How can organizations close this execution gap and evolve materiovigilance from a reactive compliance function into a proactive, data-driven discipline?

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Balancing Cyber Risk
Balancing Cyber Risk

What 524B and QMSR Change About Medical Device Risk

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.

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Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity

By Peter Justen

MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Peter Justen is Founder and CEO of AmeriTrust Solutions. He works at the intersection of technology, data, and human-centered design to improve access to government programs and streamline administrative processes. Hospitals and health systems make real-time decisions about patient care,…

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