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Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls
IEC 62304, the international standard that defines software development lifecycle requirements for medical device softwa [...]
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' [...]
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 [...]
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 [...]
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 i [...]
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 [...]
