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What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important - Featured Image

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 5...
How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips) - Featured Image

How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips)

As your company heads back from holiday breaks, what’s happening into the New Year?
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway - Featured Image

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare) - Featured Image

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

There is an old saying that the only thing that is constant in life is change. For the medical devic...
Common Mistakes That Can Tank Your FDA 510(k) Submission - Featured Image

Common Mistakes That Can Tank Your FDA 510(k) Submission

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...
Here Are the 4 Types of FDA Inspections You Need to Understand - Featured Image

Here Are the 4 Types of FDA Inspections You Need to Understand

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...
Lessons to Be Learned from Recent FDA Inspections - Featured Image

Lessons to Be Learned from Recent FDA Inspections

Something that you might find surprising is the number of medical device companies that are simply n...
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It - Featured Image

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

  My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the m...
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
What You Need to Know About the 510(k) Submission Process - Featured Image

What You Need to Know About the 510(k) Submission Process

Have you ever been through the experience of having the FDA refuse to accept your 510(k) submission?...
FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

It’s every medical device manufacturer's favorite time…the arrival of an FDA inspector or ISO audito...
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage) - Featured Image

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...

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