Recall
User Interface Software Errors Drive Medical Device Recalls: Critical Lessons for Manufacturers
By n8n Publisher |
Analysis of 2012-2015 FDA recall data reveals UI software errors as major recall driver. Learn…
Why Medical Device Recalls Can Signal a Healthy Quality System: FDA’s Perspective on Proactive Risk Management
By n8n Publisher |
Former FDA director's perspective reveals why proactive medical device recalls demonstrate robust quality systems and…
5 Critical Strategies to Reduce Medical Device Recall Risk in 2024
By n8n Publisher |
Medical device recalls jumped 10.8% in 2024. Learn five evidence-based strategies to minimize recall risk…
Understanding Medical Device Compliance: Key Regulatory Updates and Industry Best Practices
By n8n Publisher |
Explore the current medical device regulatory landscape and discover essential compliance strategies that manufacturers need…
Fast Company Spotlights Critical Gaps in Medical Device Recall Process: What Manufacturers Need to Know
By n8n Publisher |
Fast Company highlights critical gaps in medical device recall processes, emphasizing the need for manufacturers…
High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons
By n8n Publisher |
Major 2024 medical device recalls including BioZorb, Cartiva, and Impella have triggered extensive litigation, revealing…
FDA Issues Class I Recall for Q’Apel Medical Aspiration System: Critical Compliance Lessons for Device Manufacturers
By n8n Publisher |
FDA upgrades Q'Apel Medical's aspiration system recall to Class I status, affecting 1,617 units. Learn…
Medtronic Pipeline Vantage 027 Urgent Recall: Critical Compliance Lessons for Medical Device Manufacturers
By n8n Publisher |
Medtronic's urgent Pipeline Vantage 027 recall offers critical compliance lessons for medical device manufacturers on…
Urgent HeartSine AED Recall at Costco Canada: Critical Compliance Lessons for Medical Device Manufacturers
By n8n Publisher |
Health Canada's urgent recall of HeartSine AED components sold at Costco highlights critical post-market surveillance…
Understanding Medical Device Recalls: A Complete Guide for Manufacturers
By n8n Publisher |
Learn the three classes of medical device recalls, voluntary vs mandated processes, and essential compliance…
