I use a FDA and CE registered sub-contract manufacturer for a FDA and CE registered Class 2a hand-held device., which my company sells around the world (in small numbers). We have implemented the UDI requirements. All fine. The issue comes when the m...

A single-member LLC with a non-US alien owner wants to sell Class I, 510(k)-exempt medical device via Amazon FBA. The manufacturer of the device is a foreign business entity and has a valid FDA registration. The LLC wants to sell the medical device a...

I frustrated regulatory expert Michelle Lott because, despite us having discussed it many times, I still couldn't grasp how draft documentation can screw up FDA submissions. Bless her Southern heart, she persevered. We recorded the call and you can u...

Guest author Mark Proulx has seen a lot of head-shaking choices from prospective clients. I say "prospective" because, after conversations like the one below, he stayed clear of their impending disaster. Do yourself a favor: Don't say this to your au...

Even though the Corrective and Preventive Action (CAPA) process is at the heart of any quality management system, CAPA violations are the most frequently observed Quality System subsystem cited by FDA. It happens year after year – and regardless of t...

Organizations today are faced with a growing list of new and changing standards, and keeping pace with them has become increasingly difficult. It’s hard enough to manage regulations in one country, much less multiple countries. How are the most effic...

Government agencies in the US, UK, EU and elsewhere now are mandating electronic product data submissions. And major customers including Group Purchasing Organizations and hospital networks need access to the data in a standard format. That’s where t...

As originally asked by

As originally asked by Brad Brenner. Jennifer Finetti Communications | Writing | Advocacy | Marketing | Outreach for Education / Higher Ed, EdTech and more Marketing and promotion of off-label uses is strictly prohibited and highly regulated. The onl...

As originally asked by Graham Ball. The company I am working with supply a part which is built into monitoring and control devices used in the medical field. None of the devices are implanted in any way. Our customer supplies the final product to the...