Blog

Blog
Archive

Medical device

Quality

SaMD

Template

July 27, 2024

How to prepare your quality system for commercialization

Medical device

Product Development

Regulatory

Template

Guide

July 27, 2024

Human Factors Validation for Medical Devices

Machine Learning

Medical device

Product Development

Quality

July 27, 2024

Navigating the AI Lifecycle Management Model: A Playbook for Medical Device Developers

Regulatory

Product Development

Medical device

July 23, 2024

AI and ML in Radiology and Regulatory Frameworks

Medical device

Regulatory

July 3, 2024

FDA Resources for COVID-19

Regulatory

Product Development

Quality

Medical device

July 1, 2024

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

Regulatory

Medical device

July 1, 2024

What is an FDA Pre-Submission?

Regulatory

Product Development

Quality

Strategy

July 1, 2024

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

Regulatory

Medical device

Marketing

June 26, 2024

FDA Draft Guidances: Social Media Advertising Promotion

Marketing

Strategy

June 26, 2024

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

Regulatory

June 26, 2024

FDA Guidance on Digital Health Devices For Treating Psychiatric Disorders during COVID-19

Marketing

June 26, 2024

The Emotional State of Consumers during COVID-19

Marketing

Branding

June 26, 2024

Nailing the Basics: What is Branding?

Content Marketing

SEO

June 26, 2024

User-friendly content with SEO best practices

Product Development

June 26, 2024

Why it’s time to transition from outputs to outcomes

Machine Learning

Regulatory

June 25, 2024

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

Machine Learning

Product Development

Quality

Regulatory

SaMD

June 25, 2024

FDA, MHRA, Health Canada AI Update: Transparency Princples for Machine Learning-Enabled Medical Devices

Machine Learning

Medical device

Product Development

Regulatory

June 25, 2024

FDA Greenlights Revolutionary Skin Cancer Detection Device and the Regulatory Implications for Future AI/ML-enabled devices

Machine Learning

Medical device

Product Development

Quality

Regulatory

June 17, 2024

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

Medical device

Regulatory

Product Development

June 17, 2024

Navigating Risk Management for AI/ML Medical Devices

Medical device

SaMD

Quality

June 17, 2024

Introducing Digital QMS Toolkits for SaMD Startups

Regulatory

Machine Learning

Medical device

Strategy

June 3, 2024

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

Medical device

Regulatory

Marketing

Product Development

Quality

May 8, 2024

RAC Medical is now Cosm®

Regulatory

Strategy

January 29, 2024

FDA Demystifies AI/ML devices for Product Development

Medical device

Regulatory

January 24, 2024

Explore key EU MDR updates and strategies for effective clinical evaluations

Medical device

Regulatory

January 24, 2024

The Promise and Peril of Large Language Models for Global Health

Medical device

Regulatory

December 22, 2023

FDA Perspective on Prioritization software vs Triage Software

Cybersecurity

Medical device

Regulatory

November 7, 2023

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

Medical device

Regulatory

Strategy

November 7, 2023

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

Medical device

Regulatory

Strategy

November 7, 2023

FDA's Breakthrough Devices Program Update October 2023

Medical device

Product Development

Regulatory

Strategy

May 4, 2023

Overview of the UK’s New Approach to AI

Medical device

Regulatory

Strategy

May 1, 2023

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

Regulatory

Medical device

March 21, 2023

EU AI Act Impact on Medical Devices

Medical device

Regulatory

January 15, 2023

FDA Breakthrough Device Update

Medical device

Regulatory

January 15, 2023

FDA Medical Device Regulations Overview

Medical device

Regulatory

Strategy

January 15, 2023

FDA Clinical Decision Support Update

Medical device

Quality

October 3, 2022

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

Medical device

Regulatory

Cybersecurity

September 29, 2022

NIST Cybersecurity Resource Guide

Medical device

Regulatory

Strategy

September 16, 2022

FDA Review Process for 510(k)

Regulatory

Medical device

May 29, 2022

FDA Regulatory Framework Overview for Promotion of Medical Devices

Medical device

May 27, 2022

Blog

Blog Archive

How to prepare your quality system for commercialization

Human Factors Validation for Medical Devices

Navigating the AI Lifecycle Management Model: A Playbook for Medical Device Developers

AI and ML in Radiology and Regulatory Frameworks

FDA Resources for COVID-19

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

What is an FDA Pre-Submission?

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

FDA Draft Guidances: Social Media Advertising Promotion

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

FDA Guidance on Digital Health Devices For Treating Psychiatric Disorders during COVID-19

The Emotional State of Consumers during COVID-19

Nailing the Basics: What is Branding?

User-friendly content with SEO best practices

Why it’s time to transition from outputs to outcomes

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

FDA, MHRA, Health Canada AI Update: Transparency Princples for Machine Learning-Enabled Medical Devices

FDA Greenlights Revolutionary Skin Cancer Detection Device and the Regulatory Implications for Future AI/ML-enabled devices

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

Navigating Risk Management for AI/ML Medical Devices

Introducing Digital QMS Toolkits for SaMD Startups

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

RAC Medical is now Cosm®

FDA Demystifies AI/ML devices for Product Development

Explore key EU MDR updates and strategies for effective clinical evaluations

The Promise and Peril of Large Language Models for Global Health

FDA Perspective on Prioritization software vs Triage Software

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

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

FDA's Breakthrough Devices Program Update October 2023

Overview of the UK’s New Approach to AI

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

EU AI Act Impact on Medical Devices

FDA Breakthrough Device Update

FDA Medical Device Regulations Overview

FDA Clinical Decision Support Update

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

NIST Cybersecurity Resource Guide

FDA Review Process for 510(k)

FDA Regulatory Framework Overview for Promotion of Medical Devices

How to determine if your product is a medical device

Blog
Archive