Archimedic Blog

If you're building medical devices, there's an "AI" that will determine your time to market far more than the one in every headline right now. It's the Additional Information request, and understandin...

Are Investigational Device Exemption (IDE) trials a burden or asset?

Truth is, they can be either, depending on how they're designed.

Ask most device teams about IDE trials, and you'll hear about bu...

The FDA published its mid-year device authorization numbers and the news is bittersweet.

More devices are getting approved in 2026 than at this point last year (good news), but the time it's taking to ...

Are you adapting an existing quality system from QSR to QMSR/ISO 13485?

If so, you're not alone, and you may be finding that the transition isn’t completely seamless.

To bring everyone up to speed, ...

Is your product a medical device…or is it not?

It is a seemingly simple question. However, we often talk with innovators who are unsure about the answer.

The ramifications are real, and often existe...

MedTech Innovator announced its 2026 accelerator cohort. Congrats if you're one of the lucky few! 65 companies were selected from 1,835 applicants. MTI has a 93% ten-year survival rate among alumni, a...

FDA clearance is not the finish line.

Most founders know that. What fewer plan for is that it might not even be a pit stop with a defined length. As any F1 fan will tell you, an unexpected pit stop of ...

FDA Pre-Submissions are one of the most underused tools in early-stage device development.

Many founders don't know this conversation is even available to them.

A Pre-Sub is a formal mechanism throu...

Why do so many medical devices fail to make it to market? The market is there. The concept is novel. The technology is achievable. It can’t NOT work, right?

And yet, the vast majority of medical devi...

Quick 510(k) = Quick exit. Right? Not quite.

Here's some interesting data in the chart below. The data is a bit dated. But the push for the quick 510(k) happens just as much today as it did back when...

In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations, quality managers primarily focus on identifying and ...

In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between Design, Quality, and Regulatory functions. Questions ...