Management approach

Delivery of high-quality products is key to our culture, reputation, business, and our role as a trusted partner. We aim to develop products that enable patients to enjoy long, healthy, and happy lives. To remain a trusted partner to patients and healthcare professionals, we are committed to maintaining the high quality of our products.

We have a robust quality system that starts with the initial design concept, risk management, and product specification, and continues through the design of the product, packaging and labeling, and the manufacturing, sales, support, and servicing of the product. The quality system is intended to design quality into the products and uses continuous improvement concepts, including Lean/Six Sigma principles, throughout the product lifecycle.

We understand that quality is the responsibility of all of Edwards’ employees. During onboarding, we train employees on the components of our Quality Management System (QMS) through a combination of in-person and online courses. The depth and breadth of the assigned training varies based on each individual role and its associated impact on product and patient safety. Similarly, we require employees to complete annual training and recertifications on the QMS commensurate with the potential impact of their role on product or patient safety.

We communicate the Edwards quality and safety standards to suppliers through the specifications and requirements in every purchase order as well as in our Supplier Quality Agreements.

Regulatory compliance for quality

As a medical technology company, Edwards must comply with strict regulatory requirements regarding the design, development, manufacture and distribution of our products and services. The regulations impacting Edwards’ activities are set by governing bodies such as the FDA, European competent authorities, and similar organizations within the other countries where we manufacture and distribute our products, as well as international standard setting organizations, such as the International Organization for Standardization. Regulatory approvals and applicable certifications are subject to audits of a company’s quality system by regulators, notified bodies, and other independent outside auditors.

We designed the Edwards company-wide Quality System, managed by our Corporate Quality Team, and defined in our Quality Manual, to ensure our products and services satisfy customer requirements while complying with regulatory requirements in every country where we do business. The regulatory requirements we adhere to include, but are not limited to, the following:

• ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes*
• ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices
• U.S. Federal Food, Drug, and Cosmetic Act
• 21 CFR part 11 – Electronic Records; Electronic Signatures
• 21 CFR part 820 – Quality System Regulations
• (EU) 2017/745, European Medical Device Regulations
• Canadian Medical Device Regulations (CMDR)
• Medical Device Single Audit Program (MDSAP)
• Japan Pharmaceutical and Medical Device Act (PMD Act)
• Australian Therapeutic Goods Act 1989 and associated regulations
• Brazilian Good Manufacturing Practices (RDC ANVISA 665/2022)
• China Regulations on Supervision and Administration of Medical Devices (Decree No.739)

*For manufacturers of medical devices, ISO 13485:2016 is a widely accepted standard for demonstrating compliance to certain worldwide laws and regulations. The ISO standard defines the comprehensive requirements for a Quality Management System and enables a consistent output. The Edwards Lifesciences LLC ISO 13485:2016 Certification includes the design, development, production, and distribution of:

• Biological Surgical Heart Valves and Accessories (Delivery System and Inflation Device, Handles, Sizers, Trays, Suture Fastener, Heart Support Device)
• Transcatheter Heart Valve Systems (Biological Heart Valves, Delivery Systems, Balloon Catheters) and Accessories (Access Devices, Inflation Devices and Crimpers)
• Transcatheter Valve Repairs and Replacement Systems (Implants, Delivery System) and Accessories (Insertion Accessories, Loading System, Dilator Kit, Stabilizer, incl. Base Plate)
• Annuloplasty Rings and Accessories (Handles, Sizers, and Trays)
• Biological Pericardial Patches for the Area of Heart Valve Replacement, Repair and Reconstruction
• Catheters, Cannula and Occlusion Devices and Accessories (Introducers Sheaths, Percutaneous Insertion Kits)
• Hemodynamic Monitoring Equipment and Disposables; Medical Devices used for the Diagnosis of Coronary Artery Disease; Medical Devices used in the Diagnosis and Treatment of Peripheral Vascular Disease; and Medical Devices for the Treatment of Diseases of the Heart and the Central Circulatory System

Internal quality controls

We use a Global Product Complaint Handling System to collect, analyze, and manage customer feedback regarding Edwards’ products. We provide appropriate training to employees, and we require them to report customer complaints no more than 48 hours after receipt. We assess all feedback to continually improve our products to meet customer and patient needs.

For more information on internal quality controls, please review the strategy execution section of our Product Safety & Quality governance map.

The Edwards Production System

To complement our overarching Quality System, we have initiatives to streamline and improve our product manufacturing processes. Through the Edwards Production System, we aim to reduce waste, use inventory more efficiently, and reduce cycle times, all while improving the quality and performance of our products. We plan to create our Smart Factories based on Lean and Six Sigma principles, with focused investments in digital solutions, strategically sequenced to advance the way we manufacture our products and enable growth. We will also incorporate the automation of critical inspections, manufacturing execution systems (MES), and Supervisory Control and Data Acquisition (SCADA).

Managing product recalls

We designed our Quality System to be reliable, agile, innovative and patient-focused to provide the highest quality, industry-leading products and solutions. We consistently strive to fulfill our commitment to patient safety and have robust internal processes to identify trends and signals that may indicate a need for product improvements or remediation. To support the response, we have systems in place for necessary actions to correct and prevent the recurrence of the issue.

In the case of a recall, we commit to resolving issues by following the regulations of the impacted jurisdictions. We have a target to achieve no significant disruption of product availability, which aligns with the United Nations Sustainable Development Goal 3: Good Health and Well-Being.

In the U.S., the FDA categorizes recalls into three classes:

• Class I: Reasonable probability that the use of the product will cause severe adverse health consequences or death.
• Class II: Use of the product may cause temporary or medically reversible adverse health consequences.
• Class III: Use of the product is not likely to cause adverse health consequences.

Within the European Union, manufacturers must submit a field safety notice to inform the National Competent Authorities of any action taken to reduce risk of death or serious deterioration in health associated with the use of a medical device already on the market.

For more information on how we use feedback mechanisms and conduct corrective actions, please refer to our Product Safety & Quality governance map.

Managing clinical research

Clinical research is a critical component of our ability to create products that address the unmet needs of patients. We follow all applicable regulatory requirements and are committed to the highest ethical standards in our clinical research. We follow all applicable federal, state and local laws, rules and regulations pertaining to the conduct of the study, including standards for good clinical practice to protect patient safety.

For all our clinical studies, patients complete the informed consent and, if in the U.S., HIPAA Authorization processes prior to the initiation of research activities. Applicable clinical studies are conducted with the initial and continuing approval of an independent Ethics Committee or Institutional Review Board and we routinely use independent Data Safety Monitoring Boards and/or Clinical Event Committees in accordance with FDA Guidance for clinical trial sponsors.