Medical Device Insights

Practical, plain-English guides written for lean device teams.

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Regulatory

Which FDA Pathway is Right for Your Medical Device?

Wondering which FDA pathway is right for your medical device? This article breaks down the key differences between 510(k), PMA, and De Novo — so you can find the clearest route to market for your device.

4 min read
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Clinical (CRO)

Top Preclinical Testing for Medical Device Approval: What You Need to Know

Before a medical device can reach patients, it must pass a rigorous battery of preclinical tests to ensure safety and efficacy. This article breaks down the five essential evaluations, from biocompatibility to electrical safety, that manufacturers need to complete before pursuing regulatory approval.

5 min read
Read article →.
Regulatory

Step-by-Step: How to Prepare a Successful 510(k) Submission

Bringing a medical device to market through the FDA 510(k) pathway requires careful planning — from selecting the right predicate device to compiling documentation and testing data. Prime Path's latest guide walks through each step to help you avoid common pitfalls and move toward clearance with confidence.

5 min read
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Regulatory

Do You Really Need Animal Studies for a Medical Device?

Animal studies for medical devices can add cost and time with limited value. Bench testing and biocompatibility standards often provide enough safety evidence to reach first-in-human faster.

5 min read
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Regulatory

A Complete Guide to FDA Medical Device Classification

Correctly classifying your medical device is key to a smooth FDA approval process. Choosing the right classification at the start of the process helps streamline regulatory requirements.

5 min read
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Quality

How to Create an Effective Medical Device Quality Management System (QMS)

In the medical device industry, ensuring product safety, effectiveness, and compliance with regulatory standards is paramount.

6 min read
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Regulatory

How To Choose A Predicate Device for FDA 510(k) Clearance

A 510(k) is a marketing submission to the FDA made by a manufacturer to demonstrate that a new device is substantially equivalent to an existing "predicate device."

4 min read
Read article →.
Regulatory

Which FDA Pathway is Right for Your Medical Device?

Wondering which FDA pathway is right for your medical device? This article breaks down the key differences between 510(k), PMA, and De Novo — so you can find the clearest route to market for your device.

4 min read
Read article →.
Regulatory

Step-by-Step: How to Prepare a Successful 510(k) Submission

Bringing a medical device to market through the FDA 510(k) pathway requires careful planning — from selecting the right predicate device to compiling documentation and testing data. Prime Path's latest guide walks through each step to help you avoid common pitfalls and move toward clearance with confidence.

5 min read
Read article →.
Regulatory

Do You Really Need Animal Studies for a Medical Device?

Animal studies for medical devices can add cost and time with limited value. Bench testing and biocompatibility standards often provide enough safety evidence to reach first-in-human faster.

5 min read
Read article →.
Regulatory

A Complete Guide to FDA Medical Device Classification

Correctly classifying your medical device is key to a smooth FDA approval process. Choosing the right classification at the start of the process helps streamline regulatory requirements.

5 min read
Read article →.
Regulatory

How To Choose A Predicate Device for FDA 510(k) Clearance

A 510(k) is a marketing submission to the FDA made by a manufacturer to demonstrate that a new device is substantially equivalent to an existing "predicate device."

4 min read
Read article →.
Quality

How to Create an Effective Medical Device Quality Management System (QMS)

In the medical device industry, ensuring product safety, effectiveness, and compliance with regulatory standards is paramount.

6 min read
Read article →.
Clinical (CRO)

Top Preclinical Testing for Medical Device Approval: What You Need to Know

Before a medical device can reach patients, it must pass a rigorous battery of preclinical tests to ensure safety and efficacy. This article breaks down the five essential evaluations, from biocompatibility to electrical safety, that manufacturers need to complete before pursuing regulatory approval.

5 min read
Read article →.

Insights on Demand

Video guides to help device companies move forward with confidence.

How to Choose the Best Predicate Device for Your 510(k) Submission

The right predicate can make or break your 510(k). Learn how to identify strong candidates and avoid the mistakes that cause costly FDA delays.

How to Submit a 510(k) to the FDA | Step-by-Step Guide for Medical Device Approval

Ready to submit your 510(k)? We walk through what to prepare, how to organize your submission, and what the FDA expects during review.

Navigating Your Medical Device Journey

From first concept to market launch, get a clear overview of every stage of the device journey — design, quality, regulatory, and clinical.

Understanding Which FDA Pathway is Right for Your Medical Device

510(k), De Novo, or PMA? We break down how the pathways work for each device type and how to pick the fastest compliant path to market.

What is FDA Approval and How Do I Get it?

What does "FDA approved" actually mean? Learn the difference between approval and clearance, which applies to your device, and how to earn it.

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