AssurX Blog | Enterprise Quality & Compliance Management Topics

2304, 2015

FDA’s Action Plan Demands Some Industry Action, Too

AssurX Blog2015-04-23T08:10:42+00:00April 23rd, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed by the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), and the C [...]

2004, 2015

FDA Works to Clarify Device Data Collection Priorities
FDA Works to Clarify Device Data Collection Priorities

FDA Works to Clarify Device Data Collection Priorities

AssurX Blog2025-05-19T19:08:28+00:00April 20th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

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 [...]

904, 2015

FDA Plays Catch Up In Brave New World of Electronic Consent
FDA Plays Catch Up In Brave New World of Electronic Consent

FDA Plays Catch Up In Brave New World of Electronic Consent

AssurX Blog2025-05-19T19:09:27+00:00April 9th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

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 [...]

1103, 2015

Brookings Looks to Advance Medical Device Postmarket Surveillance System

AssurX Blog2025-05-19T19:10:41+00:00March 11th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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 [...]

203, 2015

FDA Gives MDDS World a Big Break
FDA Gives MDDS World a Big Break

FDA Gives MDDS World a Big Break

AssurX Blog2025-05-19T19:11:41+00:00March 2nd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

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 [...]

902, 2015

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers
There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

AssurX Blog2015-02-09T09:27:05+00:00February 9th, 2015|Archives, FDA Regulated Industries, Quality Management|

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 [...]