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Quick tips

Quick Tip - Tune Into FDA Direct Podcast with Commissioner Makary
If you want to stay updated with latest FDA news and priorities, tune into the FDA Direct podcast with Commissioner Marty Makary.
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Naveen Agarwal, Ph.D.
Quick Tip - Use FDA guidance and worksheet for benefit-risk evaluation
Benefit-risk evaluation of a medical device often proves to be challenging in practice. Here is a practical approach and a case study you can apply in…
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Naveen Agarwal, Ph.D.
Best practices for success with PCCP
Predetermined Change Control Plan (PCCP) is an excellent tool for speed to market, but it requires strategic and disciplined approach. Consider these…
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Naveen Agarwal, Ph.D.
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Quick Tip: Beware of bias in your CAPA problem statement
Defining your CAPA problem statement prematurely without a good understanding of the event(s) introduces bias in your problem solving approach. This…
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
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