CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical [...]
RAPS Preview: FDA CDRH Director Shuren Talks Priorities
FDA CDRH or Center for Devices and Radiological Health Director Jeff Shuren, MD, JD, will outline the agency's ambitious 2017 goals at a vitally important session that's part of the RAPS Convergence [...]
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 starting August 14, 20 [...]
FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism
Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Center for Devices & Radiological Health) new proposed guidance development and goals for 2015 reminds industry not to [...]
CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate
The Center for Devices and Radiological Health or CDRH will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014-2015 Strategic Priori [...]
AssurX Complaint Management Review Demo
DEMO VIDEO Full-cycle complaint management from initiation through resolution. Process complaints with control and confidence. Within the QMS, complaint management software enables manufacturers t [...]
AssurX Quality Management Review Demo
DEMO VIDEO Authenticate and Improve Your Quality Processes Automating the quality management review process for greater process efficiency: Quality management reviews (QMRs) are a necessary and va [...]
6 Common Reasons External Quality Audits Fail
In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. The FDA and other [...]
FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufacturers. It applies equally to animal food manufacturers. Recently, the FDA released updates for animal food guidance, sp [...]
8 CAPA KPIs You Should Be Measuring Now
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS) and critical to the Plan-Do-Check-Act process approach. Like any quality process, tracking CAPA KPIs ( [...]