Articles by n8n Publisher
Tandem Diabetes t:slim X2 Insulin Pump Correction: Critical Lessons for Medical Device Manufacturers
By n8n Publisher |
Tandem Diabetes' t:slim X2 correction highlights critical lessons for manufacturers on component risk assessment and…
FDA Early Alert: Medtronic Cardiac Cannula Defect Exposes Critical Quality Control Gaps
By n8n Publisher |
FDA issues Early Alert for Medtronic cardiac cannula defect, signaling enhanced regulatory oversight. Critical compliance…
FDA Issues Updated Alert on Olympus Endoscope Accessories: Critical Force/Irrigation Plug Safety Issue
By n8n Publisher |
FDA issues updated alert on Olympus endoscope accessories involving force/irrigation plug safety issues as part…
FDA Updates Bard Peripheral Atherectomy Catheter Alert: Key Compliance Lessons for Device Manufacturers
By n8n Publisher |
FDA's updated alert on Bard atherectomy catheters signals new recall communication standards. Learn what manufacturers…
FDA Early Alert: BD Infusion Set Performance Issues Signal New Recall Communication Strategy
By n8n Publisher |
FDA issues Early Alert for BD infusion set issues as part of new Communications Pilot,…
FDA Early Alert: Boston Scientific Defibrillation Lead Safety Issue Under Enhanced Recall Program
By n8n Publisher |
FDA issues Early Alert on Boston Scientific defibrillation lead as part of enhanced recall communication…
2024 Medical Device Recalls: Key Trends and Compliance Lessons for Manufacturers
By n8n Publisher |
2024 saw intensified regulatory scrutiny of medical device recalls. Learn key trends, compliance lessons, and…
Critical Medical Device Recalls in May 2025: What Manufacturers Must Know
By n8n Publisher |
May 2025 medical device recalls affected critical procedures including craniotomies and infant ventilation. Learn key…
April 2025 Medical Device Recalls Drop Significantly: Abbott HeartMate Accessory Recall Analysis
By n8n Publisher |
April 2025 saw only one medical device recall - an Abbott HeartMate accessory. Learn why…
FDA Launches Pilot Program to Accelerate High-Risk Medical Device Recall Communications
By n8n Publisher |
FDA's CDRH launches pilot program to speed recall communications for high-risk medical devices, requiring manufacturers…
