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The Initial Importer operating system includes detailed procedures for: - Complaint Handling and Trending - Medical Device Reporting - Remedial Action / Recall - Product Hold - Supplier Management - Document and Change Control - Management Review - Corrective and Preventative Action - Internal Audits - Training and Job Descriptions About GPMG: Global Pacific Manufacturing Group LLC is a privately held medical device consulting firm that assists medical device manufacturers of all sizes with product development and regulatory compliance globally.
Edwards did not offer more details but said it has since corrected its training procedures on the medical device reporting process and it "does not expect this matter to have any impact on product approvals.
Medical Device Reporting (MDR) database has a collection of information on medical devices that may have malfunctioned or caused a death or serious injury during the years 1992 through 1996.
Tailored for use by all levels of staff--from receptionists to product managers, quality assurance professionals, engineers and even corporate executives--mdi's On-Demand program has three programs in place to start: FDA QSR/cGMP requirements for medical device companies; information on complying with the FDA's design control requirements; and dealing with CAPA complaints, medical device reporting and installation.
The letter concerns procedures and implementation of corrective and preventative action under Current Good Manufacturing Practices (CGMP) requirements, as well as the acquisition and reporting of information required under the Medical Device Reporting (MDR) regulation.
The agreement stipulates that prior to resuming operations, Physio-Control must satisfactorily undergo an FDA inspection related to Good Manufacturing Practice and Medical Device Reporting.
EndoVascular Technologies will focus its compliance activities on complaint handling and medical device reporting.