Sitemap - 2025 - Let's Talk Risk!
SNIP Your Way Through Noise to Confidently Detect Safety Signals
Quick Tip: Cybersecurity is more than data security for medical devices
LTR 95: The case for software risk management in AI-driven home health devices
LTR 94: The road ahead for PCCPs and AI/ML amidst chaos at the FDA
Quick Tip: Apply good usability practices for device safety and market success
LTR 93: AI use cases in MedTech regulatory applications
LTR 92: Understanding the notified body perspective on clinical evaluation
Quick Tip: IEC 60601 is more than just electrical safety
LTR 91: International conference on medical device safety risk management
Medical Device News Update - January 2025
Quick Tip: Drive risk decisions using data, not emotions
LTR 90: Lead with empathy to grow your Quality career
LTR 89: Navigating uncertain times at the FDA
Quick Tip: There is Big Difference Between Clinical Evaluation and Clinical Investigation
LTR 88: Decoding Privacy Laws in Clinical Research
LTR 87: A Strategic Approach to Regulatory Success with GenAI Devices
Quick Tip: Three Pillars for Defining Your IVD Risk Management Strategy
LTR 86: Managing Post-Market Design Changes
Medical Device News Update - December 2024
Quick Tip: Carefully consider human factors for AR/VR devices
LTR 85: The problem with CAPA problem statements
Quick Tip: Define the indications for use carefully for regulatory success
LTR 84: Think of human factors for AI as levels of automation
LTR 83: Road to market for AI devices in the EU just got more complex
Quick Tip: Risk-based approach is an operating philosophy, not a specific tool
LTR 82: Tips for Regulatory Success with AI Devices in Radiology
Quick Tip: Medical device cybersecurity requires a new mindset
LTR 81: 4 key themes in risk management and an upcoming conference