News

AI can draft a lot of your 510(k), but it isn’t always right. A real example of AI picking the wrong predicate, and why a human review still matters.

A short video on who I am and the three ways we can work together to get your device through FDA.

More SOPs don’t make you more compliant. Why a lean, well-built QMS beats a sprawling document library, and three questions to ask before you write another procedure.

AI can help you write a regulatory submission. It can’t tell you if it’s right. Where AI actually helps with a 510(k), and where you still need experienced eyes.

Registration renewals, new FDA user fees, generative AI comments and more. Five FDA moves from October that matter if you’re building a medical device.

CDRH is piloting a new program that will impact the use of recognized consensus standards. The initiative is called the Accreditation Scheme for Conformity Assessment, or ASCA.

The FDA gave a very informative webinar about the new Quality in 510(k) review program pilot.

If you are in the medical device industry and sell product in the European Union (EU) you are familiar with the date of May 26, 2020. It’s the day that manufacturers must comply with the EU’s Medical Device Regulation, more affectionately known as the MDR.

The FDA released a DRAFT guidance for The Special 510(k) Program. The draft is an update to the

The regulatory path is often ignored throughout the initial phases of design, which can create costly delays later on. Avoid this be asking these key questions.

The following is a checklist that outlines the basic parameters of a solid regulatory and quality program foundation.