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FDA Regulations

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

June 22, 2022
What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach... Read More
Product Development

Approaching Cybersecurity & Usability as a SaMD Company

May 27, 2022
How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give... Read More
Medical Device Product

How to Build a Medical Device Business Case in 5 Easy Steps

May 16, 2022
In business, so much of success depends on timing. A product launches too early and is misunderstood by the market; a product launches too late and becomes another face in... Read More
Medical Device Product

8 Questions That Define Your Medical Device User Needs

May 6, 2022
When people talk about design controls, they often place a lot of emphasis on design inputs and outputs, verification, transfer, and the design history file. Read More
FDA Regulations

3 Common Misconceptions About Medical Device Packaging

April 8, 2022
If you asked people what comes to mind when you say designing a medical device, you’re likely going to have responses related to design controls or the device itself. What... Read More
Product Development

IEC 62366 Explained: What You Need To Know About Usability Engineering

October 24, 2021
Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on designing a user interface (UI) that allows people to quickly understand how... Read More
Quality Management System (QMS)

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

September 19, 2021
Anyone who works in the medical device industry will tell you that quality and patient care is of the utmost importance. The ultimate reason why your products exist is to... Read More
Establishing a QMS

3 Valuable Outcomes of a Culture of Quality

March 21, 2021
Do you consider your medical device company to have a culture of quality? Read More
Product Development

What is a Traceability Matrix and How Do I Create One for My Medical Device?

March 14, 2021
You’ve probably heard a traceability matrix is something you need as part of your medical device QMS, but do you know what that actually means? Read More

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