AssurX Blog
Straight talk for regulated industries.
Time to Take a Closer Look at FDA MDDS Moves
The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as "hardware or software products that transfer, store, convert for [...]
FDA Lets MDDS Off The Regulatory Hook
FDA won't enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical image communications devices recognizing the "low risk" they pose t [...]
Unprecedented Energy Demand on Aging Grid: Important Discussions at NYISO Energy Conference
New York Independent System Operator (NYISO) had their 2014 Energy Conference in New York City at the end of June. The topics this year included; addressing the aging infrastructure, g [...]
FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers
Distilling the FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers: If someone out in there in the wild wonderful world of the Web take [...]
FDA Acts to Harmonize Global Adverse Event Reporting
FDA Acts to Harmonize Global Adverse Event Reporting - It's a small world after all. One of the by-products of globalization is the speed and spread of everything from t-shirts to medi [...]
Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer
This latest round of medical device warning letters is all about pushback. The FDA is not happy with the responses it received from Acme Monaco Corp., a New Britain, Connecticut-based [...]
