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Quick tips

Quick Tip: Tailor human factors to level of automation when using AI in medical devices
As AI-enabled applications grow into increasing levels of automation, they present new challenges for human factors. Align your approach to the level of…
Quick Tip: Apply the PDCA approach to your clinical evaluation process
Clinical evaluation is a key element of EU-MDR requirements for medical devices. Using a PDCA approach can help you establish an effective process.
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Quick Tip: Carefully define the ground truth for your AI/ML device
FDA is very concerned with your ground truth, the comparative benchmark to evaluate device performance. Define it carefully in the context of the…
Quick Tip: When designing for safety, apply a probabilistic approach
Designing medical devices for safety involves concentrating on areas where we have controls in the sequence of events and applying a probabilistic…
Quick Tip: Design your data strategy carefully for success with AI/ML model
AI/ML applications in software-based medical device applications are rising. A common issue is failing to ensure the training data sets is…
Quick Tip: Risk considerations for IVD software
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Quick Tip: How AI can help improve your CAPA process
CAPA continues to be a challenging process for most Medtech companies. Here are some of the ways you can improve your CAPA process using AI.
Quick Tip: Tackling challenges of AI/ML in MedTech
AI/ML applications in MedTech are
Quick Tip: Leverage the Q-Sub process for AR/VR product development
AR/VR applications in medical devices are growing fast. But their risks in the operating theater are not fully understood. Working with FDA through…
Quick Tip: Include cybersecurity in your post-market surveillance process
Continued monitoring of cybersecurity vulnerabilities and timely action is critical to ensuring safety and effectiveness of your medical device.
Quick Tip: Focus on the patient to foster collaboration
Developing a safe and effective medical device requires cross-functional support. A common focus on the patient can help foster collaboration to avoid…
Quick Tip: Cybersecurity is more than data security for medical devices
Security of data is no longer the only concern for cyebersecurity. When it comes interconnected medical devices, ensuring patient safety is a bigger…
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