RAC Medical is now Cosm

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

Medical device

Product Development

Regulatory

Strategy

Overview of the UK’s New Approach to AI

UK's Pro-Innovation Approach to AI Regulation

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

Regulatory

Medical device

EU AI Act Impact on Medical Devices

Overview of the 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

Medical device

Regulatory

FDA Breakthrough Device Update

Select Updates to the Breakthrough Devices Program

Medical device

Regulatory

FDA Medical Device Regulations Overview

U.S. FDA Medical Device Regulations

Medical device

Quality

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

Summary of FDA Draft Guidance Computer Software Assurance

Medical device

Regulatory

Cybersecurity

NIST Cybersecurity Resource Guide

Summary of the NIST cybersecurity resource guide updates

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

Medical device

Regulatory

Strategy

FDA Review Process for 510(k)

A guide on the FDA 510(k) review process

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.

Marketing

Branding

Nailing the Basics: What is Branding?

The benefits of investing in branding and how to stand out in a crowded market.

Marketing

Strategy

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

A refresher on understanding when and how to use both effectively.

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.

Regulatory

Medical device

Marketing

FDA Draft Guidances: Social Media Advertising Promotion

Social media advertising and promotional guidelines drafted by the FDA.

Medical device

Regulatory

FDA Resources for COVID-19

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

Marketing

The Emotional State of Consumers during COVID-19

Let’s make sure your strategy reflects where you users might be at right now.

Content Marketing

SEO

User-friendly content with SEO best practices

An integrated approach to SEO-friendly content marketing.

Product Development

Why it’s time to transition from outputs to outcomes

Building features shouldn't be the real endpoint for product teams.

Regulatory

Medical device

What is an FDA Pre-Submission?

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