swift action is critical for a successful resolution. In addition to patient lives, medical device recalls can seriously impact brand perception and public image if they are not managed with expertise. Failure to manage a recall effectively can pose significant health risks and create the potential for litigation.
Companies of all sizes depend on Stericycle ExpertSOLUTIONS' industry-leading experience to enhance the speed and effectiveness of medical device recalls and withdrawals. Our proprietary technologies and a highly seasoned field force combine to ensure that medical device recalls are handled with a focus on speed and safety, regardless of scope.
From satisfying complex FDA regulatory requirements and compliance specifications, to coordinating seamless notification and response, to managing product retrieval, field repair, or destruction, the Stericycle team is singularly qualified to address the most difficult challenges of any recall or corrective action. Members of this specialized team have extensive experience working for medical device manufacturers and regulatory agencies, equipping them with the unique expertise needed to successfully handle the most challenging events.
Assisting medical device manufacturers requires a suite of scalable solutions that can be tailored to each specific scenario. Our experience, proven practices, and collaborative processes provide medical device manufacturers comprehensive, single-source solutions. Global on-site device corrections at hospitals, physician offices, and even patient homes, ensure that potentially harmful devices are quickly and accurately repaired or removed from the market.
Whether regional, national, or global in scale, protecting patients and brands from defective devices in the marketplace requires speed. In the event of a withdrawal, recall, or consumer complaint, the Stericycle global team of field representatives rapidly mobilizes within 24 hours to correct faulty medical devices on-site, install software updates, retrieve devices for disposition, or return them to manufacturers for testing. Our fast and effective on-site visits allow for the retrieval of affected products, while follow up on-site audits verify that medical devices were removed or repaired properly.