AssurX Blog
Straight talk for regulated industries.
FDA Guidance Advises Device Makers to Think About Home-Use
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Medical device manufacturers would be well-advised to address any potential home-use product risk at the design stage [...]
FDA Spreads Regulatory Love Nationwide
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Detroit may be struggling with bankruptcy, but in a flurry of activity that would make industrialist Henry Ford proud [...]
Time to Take a Closer Look at FDA MDDS Moves
Russ King, Managing Partner, Methodsense The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as "hardware or software [...]
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 [...]
