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Are you Spending Enough Time Defining and Managing Requirements for your Medical Device? - Featured Image

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Some sources claim that one-third of your product development project should be spent on defining go...
Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart) - Featured Image

Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart)

The first half of 2020 brought record-breaking investment totals for health care companies, accordin...
Developing Pediatric Medical Devices: An Innovative Approach - Featured Image

Developing Pediatric Medical Devices: An Innovative Approach

The design and development of pediatric medical devices continue to be a challenging field.
Why Biocompatibility Should be Addressed by Every Medical Device Company - Featured Image

Why Biocompatibility Should be Addressed by Every Medical Device Company

Should your medical device company address biocompatibility? The short answer is, yes. Every single ...
How to Write a Nonconformance Report - Featured Image

How to Write a Nonconformance Report

Nonconformance is a word no quality manager wants to hear.
What is a Multiple Function Device? - Featured Image

What is a Multiple Function Device?

What is a multiple function device? From a high level, it’s a product with at least one portion that...
Challenges related to Home Use Devices - Featured Image

Challenges related to Home Use Devices

What could go wrong as more medical device products are used at home and in similar non-traditional ...
Quality Assurance vs. Quality Control in the Medical Device Industry - Featured Image

Quality Assurance vs. Quality Control in the Medical Device Industry

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...
Submitting a 510(k) using FDA's Safety and Performance Based Pathway - Featured Image

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...
Document Control for Medical Device Companies: The Ultimate Guide - Featured Image

Document Control for Medical Device Companies: The Ultimate Guide

According to the original data findings of our 2020 State of Medical Device Product Development and ...
5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
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?

The FDA has released a discussion guideline and request for feedback regarding changes in the certif...

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