All "Medical Devices" articles

What the FDA's new MDDS guidance means for you

  The medical device world, like almost every other industry on Earth, gets more digitized by the day. So it's no surprise to see industry bodies ...

Everything you need to know about the FDA 510(k) submission

  What is an FDA 510(k) submission - and how do we complete one?

8 best ISO 13485 training programs in 2023

The caliber of your organization’s ISO 13485 training has a significant impact on the success and effectiveness of your quality programs. In fact, ...

The 4 best ISO 13485 audit checklists

An ISO 13485 audit can make even the most seasoned medical device quality managers bite their nails. The standard includes 77 clauses, so there are a ...

Everything you need to know about ISO 13485

Have you spent countless stressful hours preparing for ISO 13485 certification? You’re not alone. ISO 13485 is the internationally recognized quality ...

The FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

The United State Federal Drug Administration (FDA) plans to present a draft revision of its Quality System Regulation— FDA 21 CFR 820—that brings it ...

How to manage nonconformances in medical devices

It's important for medical device manufacturers to have a clear understanding of nonconformances—often referred to as NCs—and how to properly manage ...

Understanding post-market surveillance for medical devices

After spending years developing and testing your medical device, getting it to market is an exciting achievement. But your job isn't done yet. Once ...

What is a bill of materials? A guide for medical devices

When you first embark on building a new piece of furniture, you’re usually holding a small booklet that outlines every part inside your box. Lining ...

Everything you need to know about Design History Files (DHF)

One of the most important things a medical device company can do to help bring products to market quickly is to stay organized. If your team isn't ...

What you need to know about medical device validation

When medical devices work properly, they keep us healthy, moving, monitored, and—in some cases—alive. They're a growing sector in the healthcare ...

8 impressive medical device startups to watch [2022]

As history has shown, it only takes one ground-breaking MedTech startup to change a product category forever.
1 2 3 4 5 ... 8 Next