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What is FDA's Approach to Regulating AI/ML in Software as a Medical Device? - Featured Image

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

By The RND Group on July 26, 2020
The FDA has released a discussion guideline and request for feedback regarding changes in the certif...
Top 100 Medical Device Acronyms & Terminology You Need to Know - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020
In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...
How to Validate Cloud-based Software Tools - Featured Image

How to Validate Cloud-based Software Tools

By The RND Group on June 21, 2020
Do you remember what computing tools you were using in 2002? I would guess, if you were old enough t...
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

By Jesseca Lyons on June 12, 2020
When your medical device product development project gets to Design Verification and Design Validati...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

By Jesseca Lyons on May 29, 2020
The medical device industry has a lot of acronyms. 
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem - Featured Image

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

By Nick Tippmann on April 22, 2020
What impact will the EU MDR changes have on the medical device ecosystem?
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020
A common dilemma for early stage medical device companies is their lack of expertise in medical devi...
How to Approach Verification and Validation for Cloud Software - Featured Image

How to Approach Verification and Validation for Cloud Software

By Nick Tippmann on April 15, 2020
Why is verification and validation (V&V) confusing and challenging for many medical device professio...
Design Validation vs. Human Factors Validation - Featured Image

Design Validation vs. Human Factors Validation

By Nick Tippmann on February 13, 2019
  Human factors and risk create a lot of confusion in the medical device industry. What do you need ...
Why Your Company Needs an Electronic Quality Management System - Featured Image

Why Your Company Needs an Electronic Quality Management System

By Jon Speer on August 12, 2018
It’s time to face facts: a paper-based quality management system is no longer an option. 
Understanding the 5 Phases of Medical Device Development - Featured Image

Understanding the 5 Phases of Medical Device Development

By Adnan Ashfaq on March 5, 2018
Do you have a medical device to launch? Well I have good news for you and I have bad news for you.
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

Design Validation vs. Clinical Evaluation: What’s the Difference?

By Jon Speer on June 30, 2017
How confident are you when it comes to design validation? Does this always involve clinical evaluati...

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