Sitemap - 2025 - Let's Talk Risk!
LTR 111: How to sustain and grow a community of practice in risk management
Medical Device News Update - May 2025
Case Study: A Warning Letter Exposes Issues in Risk Analysis
LTR 110: Focusing on reliability to build safe medical devices
Industry snapshot: MedTech confronting tariff headwinds amidst tepid growth
Case Study: A Promising Device Fails in the Market Due to Usability Issues
LTR 109: Focus on risk, not just testing, for biocompatibility of medical devices
3 critical gaps to address in lifecycle management of AI in MedTech
LTR 108: Databases and automation tools for clinical evaluation
Medical Device News Update - April 2025
Quick Tip: Tailor human factors to level of automation when using AI in medical devices
LTR 107: A 3-step approach to developing secure medical devices
Quick Tip: Apply the PDCA approach to your clinical evaluation process
LTR 106: Critical role of Medical Safety in device risk management
Quick Tip: Carefully define the ground truth for your AI/ML device
LTR 105: AI-based virtual auditors are coming to MedTech
Medical Device News Update - March 2025
Quick Tip: When designing for safety, apply a probabilistic approach
LTR 104: Navigating the regulatory landscape for SaMD in India
Post-Market Surveillance Workshop
Quick Tip: Design your data strategy carefully for success with AI/ML model
LTR 103: Start treating human factors as a science, not an art
Quick Tip: Risk considerations for IVD software
LTR 102: Collaboration that drives innovation, not delays
Subatack Live: Navigating the chaos at FDA
Quick Tip: How AI can help improve your CAPA process
LTR 101: Power up your career with mentoring
Substack Live: Let’s talk about cyber risk in MedTech!
Quick Tip: Tackling challenges of AI/ML in MedTech
LTR 100: What we will need to lead in the age of AI
Quick Tip: Leverage the Q-Sub process for AR/VR product development
LTR 99: An exciting growth opportunity for MedTech in India
Medical Device News Update - February 2025
Substack Live: How will tariffs affect pharma and med device supply chains
Quick Tip: Include cybersecurity in your post-market surveillance process
LTR 98: Critical role of medical safety officer in medical devices
LTR 97: Surviving chaos and uncertainty at the FDA
Quick Tip: Focus on the patient to foster collaboration
LTR 96: A patient-centric approach to medical device R&D
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