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Regulatory Tips & Pointers from a Former FDA Reviewer - Featured Image

Regulatory Tips & Pointers from a Former FDA Reviewer

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamle...
Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) - Featured Image

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...
Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program - Featured Image

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program...
4 Reasons to Get ISO 27001 Certification - Featured Image

4 Reasons to Get ISO 27001 Certification

The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry? - Featured Image

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...
Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps - Featured Image

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Understanding the Investigational Device Exemption (IDE) Process - Featured Image

Understanding the Investigational Device Exemption (IDE) Process

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...
Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry - Featured Image

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself?...
How to Use the FDA ESG (Electronic Submissions Gateway) - Featured Image

How to Use the FDA ESG (Electronic Submissions Gateway)

The most competitive medical device companies embrace technology as a tool to make systems and proce...
What is the Safer Technologies Program (STeP) and Can Your Device Use It? - Featured Image

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices f...
Why the PMA Process is so Dreaded by Manufacturers in the US Market - Featured Image

Why the PMA Process is so Dreaded by Manufacturers in the US Market

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that h...

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