Medical devices in the US (and the rest of the world) use a risk-based classification system that determines the rules […]

The key reasons for submitting a 513(g) request

eSTAR program and how to prepare for a smooth transition

Impact of IEC 623O4 and IEC 623O4–1 regulations on AI-based medical software

MDCG guidelines on the Periodic Safety Update Report (PSUR)_ How can IVD Manufacturers Benefit

We’re thrilled to announce that we’ve raised a $4M Pre Series A with Wavemaker360 and Benhamou Global Ventures, with participation […]

You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to […]

If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company […]

Your Guide to European CE Marks for Medical Devices Launching a new medical device is a highly regulated process whether […]

When manufacturers plan to launch a medical device into the United States market, one of the most crucial steps is […]

What is GSPR? The GSPR stands for General Safety and Performance Requirements as listed in Annex I of EU MDR 2017/745 and EU IVDR […]

Being in charge of a regulatory submission for a medical device means managing a complex project with various moving parts

Overview Medical device manufacturers who intend to introduce a device into commercial distribution in the United States must submit

When you are in the early stages of developing a medical device, over half of your activities are regulatory-related.

Being in charge of a product’s regulatory information is complicated enough.

In today’s conversation, we are going to discuss the top 5 reasons why you should not do it alone when submitting your 510(k) application.

If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes.