Sept. 19, 2019

Vol. 16 No. 181

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FDA Clears Siemens Healthineers’ Angiography Platform

The imaging platform is for use in surgical, vascular, oncology and interventional cardiology procedures. Read More

Abbott Receives European Approval for Two Pediatric Devices

The devices have already received FDA clearance. Read More

New Life Cited for Process Control Issues, Lack of CAPAs

The facility also lacked procedures to ensure that equipment was routinely calibrated. Read More

Tennessee Firm Hit for Inadequate Procedures

The specification developer failed to document in the design history file that design output met design input requirements. Read More