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A comprehensive guide and protocol for human factors validation
Evaluate AI/ML models in radiology with the new FDA tool
A Guide to Computational Modeling for FDA Medical Device Submissions
EU AI Act mandates AI data transparency balancing innovation and accountability
Regulatory implications of first AI skin cancer detection device for PCPs
Transparency to enhance safety and effectivenes of ML-enabled medical devices
Understanding data drift types, implications, and mitigations for AI/ML devices
Five must-haves for your quality system before a product launch
Navigating FDA pathways for AI/ML in Radiology: Ensuring Safety and Innovation
An overview of the FDA PCCP and 5 steps to create yours
Applying ISO 14971 to AI/ML medical devices: Considerations for risk management
FDA publishes Nature article on AI/ML transparency
WHO guidelines on ethics & governance for large language models in health
Explore key EU MDR updates and strategies for effective clinical evaluation
Prioritization software vs Triage Software
ANSI/AAMI SW96:2023—Key to Medical Device Cyber-Safety
FDA Finalizes the Breakthrough Devices Program Guidance
US and EU policies on AI/ML medical devices, need for transparency
UK's Pro-Innovation Approach to AI Regulation
Marketing Submission Recommendations for a PCCP of AI/ML device
Overview of the EU AI Act Impact on Medical Devices
Update on the FDA's guidance around clinical decision support software
Select Updates to the Breakthrough Devices Program
U.S. FDA Medical Device Regulations
Summary of FDA Draft Guidance Computer Software Assurance
Summary of the NIST cybersecurity resource guide updates
An overview of the FDA regulatory framework for the promotion of medical devices
A guide on the FDA 510(k) review process
Social media advertising and promotional guidelines drafted by the FDA.
An integrated approach to SEO-friendly content marketing.
A guide that could help you determine if your product is a medical device.
This marks a new chapter for us. We're excited to share our refreshed vision.
Let’s make sure your strategy reflects where you users might be at right now.
Building features shouldn't be the real endpoint for product teams.
The benefits of investing in branding and how to stand out in a crowded market.
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A refresher on understanding when and how to use both effectively.
COSM’s thoughts on Covid-19 and what companies need to know.
How to efficiently communicate with the FDA in order to gain valuable feedback.
Resources for device manufacturers to be a part of the managing crisis of 2020.
