FDA Guidances on AI-Enabled Devices
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S.
How to Avoid FDA Warning Letters
According to the U.S.
Facing Medtech Uncertainty
One of the key findings in Greenlight Guru’s 2025 Medical Device Industry Re
2025 Medical Device Industry Report
The medical device industry is growing. Data from KPMG predict that global annual sales will rise by 5% per year to reach just under $800 billion by 2030.
Three Insights on Medtech Product Development
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.
Enhancing Compliance Through Quality Risk Management
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide.
AI in Medical Device Manufacturing
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
How Testing Automation Reduces Risk and Elevates Quality Assurance
Back in 2023, only 15% of businesses had adopted AI-augmented software testing tools. By 2027, that number is expected to leap to 80%.
Common Mistakes in ISO 27001 Implementation
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS).
Medical Device Compliance
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Photo by Mufid Majnun on Unsplash
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
