AssurX Blog
Straight talk for regulated industries.
FDA Plays Catch Up In Brave New World of Electronic Consent
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated el [...]
Brookings Looks to Advance Medical Device Postmarket Surveillance System
Patients and medical device innovators will benefit if the United States is able to launch a National Device Postmarket Surveillance System (MDS), says a new report by the Brookings I [...]
FDA Gives MDDS World a Big Break
Sometimes it’s nice to be told what the FDA isn’t going to do. The agency issued a guidance last month that should give anyone building or working with a Medical Device Data System (M [...]
There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers
Ron Shoop, SVP, National Sales Manager & Strategic Alliances, Medical Web Experts As more physicians are integrating their patient EMR with third-party patient portals, they’re l [...]
Training Management Best Practices for Emerging Life Science Companies
No matter how good your written policies are, or how clean a facility you operate, or how successful you are in the marketplace, it can all fall apart without a strong handle on your o [...]
Quality Takes Time, FDA’s CDER Reminds Drug Makers
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the Fifth Century B.C. and the Sixteenth Century A.D. [...]
