AssurX Blog
Straight talk for regulated industries.
Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls
Russ King, Managing Partner, Methodsense IEC 62304, the international standard that defines software development lifecycle requirements for medical device software, was developed fro [...]
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR - No more paper. That's what the FDA requires from the medical device community starti [...]
FDA’s Action Plan Demands Some Industry Action, Too
“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 [...]
FDA Works to Clarify Device Data Collection Priorities
Michael Causey, Editor & Publisher, eDataIntegrityReport.com A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluatio [...]
FDA Plays Catch Up In Brave New World of Electronic Consent
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently remind [...]
Brookings Looks to Advance Medical Device Postmarket Surveillance System
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Patients and medical device innovators will benefit if the United States is able to launch a National Device Postmark [...]
