AssurX Blog
Straight talk for regulated industries.
FDA Works to Clarify Device Data Collection Priorities
A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms [...]
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 In [...]
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 (MD [...]
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 [...]
