Quality and Safety: Holding Ourselves to the Highest Standards

We take quality and safety seriously, knowing that patients’ lives depend on our products. This principle guides every process we undertake, and shapes everything we build and create. This is how we meet and exceed customers’, patients’ and regulators’ expectations of quality and safety.

We continually assess the safety and performance of our products. In this rapidly changing health care environment, we also look to design processes, process controls and customer feedback so we are sure we always meet the needs of our customers and their patients.

Our quality policy

St. Jude Medical is committed to providing our patients, customers and regulators with products and services that meet or exceed their expectations of safety, high-quality performance, reliability and service.

Our commitment to quality drives every aspect of our business processes and decision-making. We foster a culture of quality everywhere we do business. This means communicating our expectations to all employees and partners, leading by example and providing formal employee training on requirements for our approach to quality management.

Continuous improvement

St. Jude Medical monitors all product life-cycle stages to assess opportunities for improvement, including: device feasibility studies, product development, clinical trials, manufacturing, marketing and promotion, storage, handling, distribution, use and service. As a medical device manufacturer, our company is subject to a variety of regulations and standards for products and quality management systems and we work to ensure that continuous improvement is built into our processes and procedures.

Product and service labeling

We are also subject to a variety of regulations and standards for products and quality management systems that ensure product labeling information, including marketing materials, is accurate and controlled. For all of our products, we employ robust labeling design processes directed at creation, review and approval of device labeling that is consistent with the applicable laws and regulations of all countries where we sell products. We strive to adhere to all applicable labeling standards and where necessary, include information regarding the sourcing of components for the safe and effective use of our products.

Customer satisfaction

In support of our commitment to developing medical technology and services that contribute to successful outcomes for every patient, we have established global processes and procedures that allow customers to provide feedback. Information regarding device performance or services rendered is routinely reviewed so that customer feedback is a primary input to our continuous improvement mechanisms and to ensure that St. Jude Medical supports global regulatory medical device vigilance systems.

Marketing communications

We take a responsible stance and seek rigorous compliance with the variety of applicable regulations and standards for products and quality management systems in an effort to ensure our marketing materials including labeling, marketing communications, advertising and promotional materials are accurate and controlled. For all of our medical technologies, we employ robust design-control processes for proper review and approval of these materials that is consistent with the laws and regulations of the countries where St. Jude Medical sells products.

Our quality performance

St. Jude Medical has a strong history of product safety and reliability, and we remain dedicated to developing technologies and products that save and improve the lives of patients. Our goal as a global medical device manufacturer is to produce devices of industry-leading quality that function safely and properly every time.

We follow industry best practices in product failure analysis and regularly report on the performance of our products. Our bi-annual product performance report details product performance and reliability and significant physician advisories to notify physicians of new information about the safety and performance of select products.

Privacy and information security

St. Jude Medical takes the security of devices and their data very seriously. Protection of confidential patient and consumer information is a high priority for us, and we will remain vigilant to the ever-increasing sophistication of those seeking unlawful access to such data. St. Jude Medical has an ongoing program to perform security testing on our medical devices and networked equipment.

Given the dynamic and changing nature of cybersecurity, we also partner with experts, others in the industry and regulators, to develop appropriate safeguards for our data and devices. We continually assess our advanced processes and technology to protect patient data, our medical devices and the company’s intellectual property and business information.

Our work with a variety of firms that are experts in this area helps to develop appropriate safeguards for our data and devices. These alliances with security specialists help to make medical devices safe and serve the intended purpose of saving lives.

Inquiries about the security of our medical devices or confidential patient data can be directed to St. Jude Medical Customer Service.