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AI
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Medical device

Unlocking the Future of AI in Radiology with A new FDA-QUALIFIED Tool

Evaluate AI/ML models in radiology with the new FDA tool

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Unlocking the Future of AI in Radiology with A new FDA-QUALIFIED Tool
Regulatory
Product Development
Quality
Strategy

Leveraging Computational Modeling for Medical Device Premarket Submissions: A Comprehensive Guide

A Guide to Computational Modeling for FDA Medical Device Submissions

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Leveraging Computational Modeling for Medical Device Premarket Submissions: A Comprehensive Guide
AI
Machine Learning
Regulatory

Understanding the EU AI Act's Transparency Requirements for General-Purpose AI

EU AI Act mandates AI data transparency balancing innovation and accountability

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Understanding the EU AI Act's Transparency Requirements for General-Purpose AI
AI
Machine Learning
Medical device
Product Development
Regulatory

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

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FDA Greenlights Revolutionary Skin Cancer Detection Device and the Regulatory Implications for Future AI/ML-enabled devices
Machine Learning
Product Development
Quality
Regulatory
samd

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

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FDA, MHRA, Health Canada AI Update: Transparency Princples for Machine Learning-Enabled Medical Devices
Machine Learning
Medical device
Product Development
Quality
Regulatory

Understanding Data Drift in Medical Machine Learning: A Guide for AI/ML Developers

Understanding data drift types, implications, and mitigations for AI/ML devices

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Understanding Data Drift in Medical Machine Learning: A Guide for AI/ML Developers
AI
Regulatory
Product Development
Medical device

AI and ML in Radiology and Regulatory Frameworks

Navigating FDA pathways for AI/ML in Radiology: Ensuring Safety and Innovation

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AI and ML in Radiology and Regulatory Frameworks
Regulatory
AI
Machine Learning
Medical device
Strategy

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

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What is an FDA Predetermined Change Control Plan (PCCP) and how to create one for your AI/ML product
Medical device
Regulatory
Product Development

Navigating Risk Management for AI/ML Medical Devices

Applying ISO 14971 to AI/ML medical devices: Considerations for risk management

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Navigating Risk Management for AI/ML Medical Devices
Regulatory
Strategy

FDA Demystifies AI/ML devices for Product Development

FDA publishes Nature article on AI/ML transparency

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FDA Demystifies AI/ML devices for Product Development
Medical device
Regulatory

The Promise and Peril of Large Language Models for Global Health

WHO guidelines on ethics & governance for large language models in health

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The Promise and Peril of Large Language Models for Global Health
Medical device
Regulatory

Explore key EU MDR updates and strategies for effective clinical evaluations

Explore key EU MDR updates and strategies for effective clinical evaluation

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Explore key EU MDR updates and strategies for effective clinical evaluations
Medical device
Regulatory

FDA Perspective on Prioritization software vs Triage Software

Prioritization software vs Triage Software

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FDA Perspective on Prioritization software vs Triage Software
Cybersecurity
Medical device
Regulatory

Unveiling AAMI SW96: A New Era for Medical Device Cybersecurity Standards

ANSI/AAMI SW96:2023—Key to Medical Device Cyber-Safety

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Unveiling AAMI SW96: A New Era for Medical Device Cybersecurity Standards
Medical device
Regulatory
Strategy

FDA's Breakthrough Devices Program Update October 2023

FDA Finalizes the Breakthrough Devices Program Guidance

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FDA's Breakthrough Devices Program Update October 2023
Medical device
Regulatory
Strategy

Regulations for AI/ML-enabled Medical Devices in US and EU

US and EU policies on AI/ML medical devices, need for transparency

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Regulations for AI/ML-enabled Medical Devices in US and EU
Medical device
Product Development
Regulatory
Strategy

Overview of the UK’s New Approach to AI

UK's Pro-Innovation Approach to AI Regulation

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Overview of the UK’s New Approach to AI
Medical device
Regulatory
Strategy

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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FDA Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
Regulatory
Medical device

EU AI Act Impact on Medical Devices

Overview of the EU AI Act Impact on Medical Devices

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EU AI Act Impact on Medical Devices
Medical device
Regulatory
Strategy

FDA Clinical Decision Support Update

Update on the FDA's guidance around clinical decision support software

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FDA Clinical Decision Support Update
Medical device
Regulatory

FDA Breakthrough Device Update

Select Updates to the Breakthrough Devices Program

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FDA Breakthrough Device Update
Medical device
Regulatory

FDA Medical Device Regulations Overview

U.S. FDA Medical Device Regulations

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FDA Medical Device Regulations Overview
Medical device
Quality

FDA Update on Computer Software Assurance for Production and Quality System Software

Summary of FDA Draft Guidance Computer Software Assurance

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FDA Update on Computer Software Assurance for Production and Quality System Software
Medical device
Regulatory
Cybersecurity

NIST Cybersecurity Resource Guide

Summary of the NIST cybersecurity resource guide updates

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NIST Cybersecurity Resource Guide
Regulatory
Medical device

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 Regulatory Framework Overview for Promotion of Medical Devices
Medical device
Regulatory
Strategy

FDA Review Process for 510(k)

A guide on the FDA 510(k) review process

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FDA Review Process for 510(k)
Regulatory
Medical device
Marketing

FDA Draft Guidances: Social Media Advertising Promotion

Social media advertising and promotional guidelines drafted by the FDA.

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FDA Draft Guidances: Social Media Advertising Promotion
Content Marketing
SEO

User-friendly content with SEO best practices

An integrated approach to SEO-friendly content marketing.

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User-friendly content with SEO best practices
Medical device

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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How to determine if your product is a medical device
Medical device
Regulatory
Marketing
Product Development
Quality

RAC Medical is now Cosm®

This marks a new chapter for us. We're excited to share our refreshed vision.

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RAC Medical is now Cosm®
Marketing

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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The Emotional State of Consumers during COVID-19
Product Development

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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Why it’s time to transition from outputs to outcomes
Marketing
Branding

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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Nailing the Basics: What is Branding?
Marketing
Strategy

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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What’s the Difference between Go-To-Market and Marketing Strategies?
Regulatory

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 Guidance on Digital Health Devices For Treating Psychiatric Disorders during COVID-19
Regulatory
Medical device

What is an FDA Pre-Submission?

How to efficiently communicate with the FDA in order to gain valuable feedback.

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What is an FDA Pre-Submission?
Medical device
Regulatory

FDA Resources for COVID-19

Resources for device manufacturers to be a part of the managing crisis of 2020.

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FDA Resources for COVID-19
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