Question
Medical devices companies use modelling and simulation in the design phase but it's now possible in principle to produce evidences of safety and/or efficacy using computer models, something called In Silico Trials.FDA has produced guidelines, and the...
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...
Is there any specific time line to update the labels including the UDI/human readable requirements for the *Class* *I* and *Ir* devices.
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...
