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Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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Product Development

Top 40 IMDRF Technical Documents for Medical Devices

Etienne Nichols
March 10, 2023
The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More
Product Development

Medical Device Classification Guide - How To Determine Your Device Class

Etienne Nichols
March 7, 2023
What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach to determining how... Read More
Product Development

How to Define User Needs During Design Controls

Etienne Nichols
March 3, 2023
Every medical device begins with the same purpose—to improve the quality of life by meeting the needs of its users. Read More
Product Development

Utility Patent vs Design Patent: Choosing the Right One for Your Device

Etienne Nichols
February 28, 2023
If you go through the rigors of designing and developing a medical device, it only makes sense that you’d want to protect your intellectual property. For a physical product,... Read More
Product Development

Does My Device Labeling Comply with 21 CFR 801?

Etienne Nichols
February 28, 2023
Medical device labeling is a core requirement for getting your device onto the market. 21 CFR 801 covers general device labeling and the use of symbols. One thing the... Read More
Product Development

7 Essential Steps of a Nonconformance Report

Etienne Nichols
February 24, 2023
Nonconformance is a word no quality manager wants to hear. Read More
Product Development

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Tom Rish
February 23, 2023
Your device history record (DHR) is one of the final forms of documentation you’ll need before your product ships. That doesn’t mean it’s an afterthought, however. Read More
Product Development

What is a Class 1 Medical Device?

Etienne Nichols
February 22, 2023
In the US, the governing body tasked with regulating the medical device market is the Food and Drug Administration (FDA). More specifically, the Center for Devices and... Read More
Product Development

FDA Human Factors Guidance Draft: What Medical Device Manufacturers Need to Know

Etienne Nichols
February 19, 2023
On December 9, 2022, the FDA issued a new draft guidance,Content of Human Factors Information in Medical Device Marketing Submissions, which provides recommendations for the... Read More

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