Resources

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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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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Regulatory
Medical device

EU AI Act Impact on Medical Devices

Overview of the EU AI Act Impact on Medical Devices

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Medical device
Regulatory
Strategy

FDA Clinical Decision Support Update

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

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Medical device
Regulatory

FDA Breakthrough Device Update

Select Updates to the Breakthrough Devices Program

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Medical device
Regulatory

FDA Medical Device Regulations Overview

U.S. FDA Medical Device Regulations

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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Summary of FDA Draft Guidance Computer Software Assurance

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Medical device
Regulatory
Cybersecurity

NIST Cybersecurity Resource Guide

Summary of the NIST cybersecurity resource guide updates

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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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Medical device
Regulatory
Strategy

FDA Review Process for 510(k)

A guide on the FDA 510(k) review process

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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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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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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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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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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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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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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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Content Marketing
SEO

User-friendly content with SEO best practices

An integrated approach to SEO-friendly content marketing.

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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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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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