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Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest ...
Understanding the Difference Between a General Wellness Device and a Regulated Medical Device - Featured Image

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the pres...
8 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

8 Tips to Comply With FDA 21 CFR Part 11

  When it comes to compliance among medical device companies, there is a lot of misleading informati...
This is a What … Unforeseen Pitfalls when Classifying a Medical Device - Featured Image

This is a What … Unforeseen Pitfalls when Classifying a Medical Device

“This is a what” is not only a torturous summer-camp game, but an essential question when working to...
How FDA Interacts with Medical Devices When They Are Imported Into the US - Featured Image

How FDA Interacts with Medical Devices When They Are Imported Into the US

Does your medical device company import components, parts, or materials used in the development or m...
5 Tips for Medical Device Engineers on FDA Design Controls - Featured Image

5 Tips for Medical Device Engineers on FDA Design Controls

If you’re in the medical device industry, you may think that design controls are a confusing imposit...
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? - Featured Image

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Do you understand the difference between significant risk and nonsignificant risk when it comes to t...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...
What Devicemakers Need to Know About Medical Device Reporting (MDR) - Featured Image

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?
Top 30 Medical Device Conferences You Should Be Attending in 2017 - Featured Image

Top 30 Medical Device Conferences You Should Be Attending in 2017

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...
The Ultimate Guide to Preparing Your FDA 510(k) Submission - Featured Image

The Ultimate Guide to Preparing Your FDA 510(k) Submission

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...

The greenlight.guru Medical Device Blog

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