
Overview of the UK’s New Approach to AI
UK's Pro-Innovation Approach to AI Regulation
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FDA Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
Marketing Submission Recommendations for a PCCP of AI/ML device
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EU AI Act Impact on Medical Devices
Overview of the EU AI Act Impact on Medical Devices
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FDA Clinical Decision Support Update
Update on the FDA's guidance around clinical decision support software
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FDA Breakthrough Device Update
Select Updates to the Breakthrough Devices Program
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FDA Medical Device Regulations Overview
U.S. FDA Medical Device Regulations
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FDA Update on Computer Software Assurance for Production and Quality System Software
Summary of FDA Draft Guidance Computer Software Assurance
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NIST Cybersecurity Resource Guide
Summary of the NIST cybersecurity resource guide updates
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FDA Regulatory Framework Overview for Promotion of Medical Devices
An overview of the FDA regulatory framework for the promotion of medical devices
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FDA Review Process for 510(k)
A guide on the FDA 510(k) review process
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How to determine if your product is a medical device
A guide that could help you determine if your product is a medical device.
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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.
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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.
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FDA Draft Guidances: Social Media Advertising Promotion
Social media advertising and promotional guidelines drafted by the FDA.
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FDA Resources for COVID-19
Resources for device manufacturers to be a part of the managing crisis of 2020.
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The Emotional State of Consumers during COVID-19
Let’s make sure your strategy reflects where you users might be at right now.
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User-friendly content with SEO best practices
An integrated approach to SEO-friendly content marketing.
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Why it’s time to transition from outputs to outcomes
Building features shouldn't be the real endpoint for product teams.
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What is an FDA Pre-Submission?
How to efficiently communicate with the FDA in order to gain valuable feedback.
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