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Tips & Pointers for Effective Internal Quality Audits with Kyle Rose - Featured Image

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational.
How to Properly Use the FDA Pre-Submission Process and Why It's So Important - Featured Image

How to Properly Use the FDA Pre-Submission Process and Why It's So Important

In order to get your medical device to market, you will need to know about pre-submissions and the p...
Why Poor Design Controls Mean More Medical Device Complaints - Featured Image

Why Poor Design Controls Mean More Medical Device Complaints

I’ll venture a guess that you want to get your medical device to market ASAP!
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time - Featured Image

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...
Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer - Featured Image

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

One important piece of documentation that medical device companies rely on to get them through the r...
Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development - Featured Image

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

3D printing can impact new product development and manufacturing. It’s a technology that is hot in m...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include

DHF. DMR. DHR. It’s bad enough that medical device product development has a whole slew of new terms...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
3 Common Misconceptions About Medical Device Labeling - Featured Image

3 Common Misconceptions About Medical Device Labeling

When you first start designing and developing a new medical device, you spend a bunch of time learni...
8 Reasons Why Your Design Controls And Risk Management Processes Fail - Featured Image

8 Reasons Why Your Design Controls And Risk Management Processes Fail

Design controls and risk management processes should be tools for medtech professionals to ensure th...

The greenlight.guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.