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How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen) - Featured Image

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

  So, you haven’t completed your design controls or design history file (DHF)...
7 Common Mistakes That Can Delay Your FDA 510(k) Clearance - Featured Image

7 Common Mistakes That Can Delay Your FDA 510(k) Clearance

  The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical de...
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 greenlight.guru Medical Device Blog

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