The UDI Is on the Device. If Nobody Captures It at the Point of Care, Much of the Value Disappears.
TGA publishes new guidance for hospitals implementing UDI across inventory, clinical systems, patient records and recalls.
Category: Med-Device Compliance
A Clear IV Solution Can Still Carry a Serious Quality Risk
Baxter recalls two saline lots for potential fiberglass particulate contamination, raising injectable particulate-control questions
The Software Updated Successfully – did the Patient’s Alarm Settings Survive?
FDA warns that GE Portrait software updates can remove monitored patients and reset alarm settings, creating a clinical change-control risk.
FDA May Move Digital Breast Tomosynthesis From PMA to 510(k)
FDA has proposed reclassifying digital breast tomosynthesis (DBT) systems from Class III to Class II. If finalized, the change would replace the current PMA framework for these systems with Class II special controls plus 510(k) premarket notification requirements. For manufacturers, this could materially change both new-product submissions and lifecycle-management strategy.…
FDA QMSR 2026: Implementation guide for manufacturers
Learn new requirements of FDA QMSR implementation: How to align with ISO 13485, bridge gaps in records/labeling, prepare for risk-based inspections, and avoid shutdown risks.
FDA QMSR Draft: Secure PMA Approvals Before 2026 Deadline
Learn how FDA’s QMSR draft guidance helps secure PMA/HDE approvals pre-2026 deadline, with compliance steps, inspection changes, and transition strategies from QSR to ISO 13485.
Medical Device Traceability Regulations Drive Blockchain Adoption
Learn how blockchain enables medical device registration and traceability under FDA UDI and EU MDR, ensuring compliance, counterfeit prevention, and efficient recalls. (148 characters)
Medtech regulation shifts reshaping medtech strategy under new FDA rules
Medtech regulation shifts: Learn how to navigate new FDA changes on wearables, CDS, AI tools, and QMS, and realign strategy, risk, and compliance frameworks.
Medical Device labeling revolution reshaping medical device safety
Explore how medical device labeling, UDI, and EU/FDA regulations enhance safety, traceability, and compliance while guiding practical risk and quality management.
Regulation Roadblocks Cloud AI Integration in Real‑World Evidence
Learn how AI integration in real-world evidence demands high-quality data, robust governance, and regulatory compliance to ensure trustworthy, regulator-ready insights.