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Navigating the AI Lifecycle Management Model: A Playbook for Medical Device Developers
Explore the FDA’s AI Lifecycle Management (AILC) model
Human Factors Validation for Medical Devices
A comprehensive guide and protocol for human factors validation
Unlocking the Future of AI in Radiology with A new FDA-QUALIFIED Tool
Evaluate AI/ML models in radiology with the new FDA tool
Leveraging Computational Modeling for Medical Device Premarket Submissions: A Comprehensive Guide
A Guide to Computational Modeling for FDA Medical Device Submissions
Understanding the EU AI Act's Transparency Requirements for General-Purpose AI
EU AI Act mandates AI data transparency balancing innovation and accountability
FDA Greenlights Revolutionary Skin Cancer Detection Device and the Regulatory Implications for Future AI/ML-enabled devices
Regulatory implications of first AI skin cancer detection device for PCPs
FDA, MHRA, Health Canada AI Update: Transparency Princples for Machine Learning-Enabled Medical Devices
Transparency to enhance safety and effectivenes of ML-enabled medical devices
Understanding Data Drift in Medical Machine Learning: A Guide for AI/ML Developers
Understanding data drift types, implications, and mitigations for AI/ML devices
How to prepare your quality system for commercialization
Five must-haves for your quality system before a product launch
AI and ML in Radiology and Regulatory Frameworks
Navigating FDA pathways for AI/ML in Radiology: Ensuring Safety and Innovation
What is an FDA Predetermined Change Control Plan (PCCP) and how to create one for your AI/ML product
An overview of the FDA PCCP and 5 steps to create yours
Navigating Risk Management for AI/ML Medical Devices
Applying ISO 14971 to AI/ML medical devices: Considerations for risk management
FDA Demystifies AI/ML devices for Product Development
FDA publishes Nature article on AI/ML transparency
The Promise and Peril of Large Language Models for Global Health
WHO guidelines on ethics & governance for large language models in health
Explore key EU MDR updates and strategies for effective clinical evaluations
Explore key EU MDR updates and strategies for effective clinical evaluation
FDA Perspective on Prioritization software vs Triage Software
Prioritization software vs Triage Software
Unveiling AAMI SW96: A New Era for Medical Device Cybersecurity Standards
ANSI/AAMI SW96:2023—Key to Medical Device Cyber-Safety
FDA's Breakthrough Devices Program Update October 2023
FDA Finalizes the Breakthrough Devices Program Guidance
Regulations for AI/ML-enabled Medical Devices in US and EU
US and EU policies on AI/ML medical devices, need for transparency
Overview of the UK’s New Approach to AI
UK's Pro-Innovation Approach to AI Regulation
FDA Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
Marketing Submission Recommendations for a PCCP of AI/ML device
EU AI Act Impact on Medical Devices
Overview of the EU AI Act Impact on Medical Devices
FDA Clinical Decision Support Update
Update on the FDA's guidance around clinical decision support software
FDA Breakthrough Device Update
Select Updates to the Breakthrough Devices Program
FDA Medical Device Regulations Overview
U.S. FDA Medical Device Regulations
FDA Update on Computer Software Assurance for Production and Quality System Software
Summary of FDA Draft Guidance Computer Software Assurance
NIST Cybersecurity Resource Guide
Summary of the NIST cybersecurity resource guide updates
FDA Regulatory Framework Overview for Promotion of Medical Devices
An overview of the FDA regulatory framework for the promotion of medical devices
FDA Review Process for 510(k)
A guide on the FDA 510(k) review process
FDA Draft Guidances: Social Media Advertising Promotion
Social media advertising and promotional guidelines drafted by the FDA.
User-friendly content with SEO best practices
An integrated approach to SEO-friendly content marketing.
How to determine if your product is a medical device
A guide that could help you determine if your product is a medical device.
RAC Medical is now Cosm®
This marks a new chapter for us. We're excited to share our refreshed vision.
The Emotional State of Consumers during COVID-19
Let’s make sure your strategy reflects where you users might be at right now.
Why it’s time to transition from outputs to outcomes
Building features shouldn't be the real endpoint for product teams.
Nailing the Basics: What is Branding?
The benefits of investing in branding and how to stand out in a crowded market.
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What’s the Difference between Go-To-Market and Marketing Strategies?
A refresher on understanding when and how to use both effectively.
FDA Guidance on Digital Health Devices For Treating Psychiatric Disorders during COVID-19
COSM’s thoughts on Covid-19 and what companies need to know.
What is an FDA Pre-Submission?
How to efficiently communicate with the FDA in order to gain valuable feedback.
FDA Resources for COVID-19
Resources for device manufacturers to be a part of the managing crisis of 2020.
