Why Medical Device Recalls Can Signal a Healthy Quality System: FDA’s Perspective on Proactive Risk Management

Why Medical Device Recalls Can Signal a Healthy Quality System: FDA’s Perspective on Proactive Risk Management

Former FDA director's perspective reveals why proactive medical device recalls demonstrate robust…

5 Critical Strategies to Reduce Medical Device Recall Risk in 2024

5 Critical Strategies to Reduce Medical Device Recall Risk in 2024

Medical device recalls jumped 10.8% in 2024. Learn five evidence-based strategies to…

Understanding Medical Device Compliance: Key Regulatory Updates and Industry Best Practices

Understanding Medical Device Compliance: Key Regulatory Updates and Industry Best Practices

Explore the current medical device regulatory landscape and discover essential compliance strategies…

Fast Company Spotlights Critical Gaps in Medical Device Recall Process: What Manufacturers Need to Know

Fast Company Spotlights Critical Gaps in Medical Device Recall Process: What Manufacturers Need to Know

Fast Company highlights critical gaps in medical device recall processes, emphasizing the…

FDA Expands Early Alert Pilot Program: What Medical Device Manufacturers Need to Know

FDA Expands Early Alert Pilot Program: What Medical Device Manufacturers Need to Know

FDA expands Early Alert pilot program beyond initial five device categories, creating…

High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons

High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons

Major 2024 medical device recalls including BioZorb, Cartiva, and Impella have triggered…

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