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Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think) - Featured Image

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

When developing a new medical device, do you try to figure out the fastest and simplest way to get y...
Tips, Tricks & Best Practices for Complying with ISO 13485:2016 - Featured Image

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

When it comes to ISO 13485:2016, are you scrambling to meet requirements? Are you trying to figure o...
Helping to Prepare Biomedical Engineers Entering the Workforce - Featured Image

Helping to Prepare Biomedical Engineers Entering the Workforce

Students offer hope for our future. They will be developing products that can save our lives, or at ...
How to Ensure Your Quality Management System is Effective and Benefits Patients - Featured Image

How to Ensure Your Quality Management System is Effective and Benefits Patients

When it comes to quality management compliance, would you consider yourself a box checker or a true ...
5 Most Common Problems With Your CAPA Process - Featured Image

5 Most Common Problems With Your CAPA Process

What are the most common problems with the CAPA process?
How to Determine the Operational Quality of a Quality System Using a Performance Assessment - Featured Image

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to...
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...
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...
An Overview of What Medical Device Developers Need to Know About Human Factors - Featured Image

An Overview of What Medical Device Developers Need to Know About Human Factors

The topic of human factors can be confusing: How does it relate to design factors and risk? Why is i...
Challenges with Applying Risk Management Throughout the Manufacturing Process - Featured Image

Challenges with Applying Risk Management Throughout the Manufacturing Process

Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim...
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 ...
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions - Featured Image

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...

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