Quality in Everything We Do
We are focused on developing innovative products that work in partnership with and improve life. Our approach to quality starts and ends with customer safety. We are dedicated to rigorous compliance with all laws, standards and regulations regarding quality, safety and performance requirements in every country where we offer our products. We set high standards and focus on achieving continuous improvements in the effectiveness of our quality processes.
Our Quality teams manage our quality and safety programs, coordinating efforts across multiple functions, most notably Operations and R&D. All of our manufacturing and R&D facilities are International Organization for Standardization (ISO) 13485 certified, the quality management system standard for medical devices.
Our quality management system includes:
- Regular employee training relevant to each employee’s job, including but not limited to, mandatory new hire training, procedure training and product training for customer-facing employees;
- An extensive supplier management process that selects, qualifies, manages and monitors suppliers in a consistent and effective manner to ensure that all purchased products and services are controlled and conform to specified requirements;
- Product development processes that leverage current best practices in project management, engineering, clinical science and manufacturing to maximize benefits to patients while assuring safety; and
- Management oversight to set and continuously improve product and service specifications, as well as key performance indicators for our internal quality management systems. This includes a Corrective and Preventative Actions (CAPA) program to help ensure we have a robust process in place to identify potential issues and to take action
In addition, we monitor state-of-the art practices and global standards through active participation in organizations such as ISO and through membership in organizations such as AdvaMed, Medical Device Manufacturers Association and MedTech Europe.
LivaNova is committed to enabling access to our products. We work with reimbursement and health technology agencies to ensure sustained and affordable access to LivaNova products for patients, and we partner with industry groups around the world to support policies that enable access. One area of focus is on solutions for resource-limited providers of care and accelerating access for patients who are distant from care facilities, for example, via remote monitoring.
LivaNova is committed to interacting with healthcare providers in an ethical and responsible manner, and with the best interests of customers always in mind.
We have established mandatory policies and procedures that all employees, consultants, contract workers and temporary staff must follow when interacting with healthcare professionals and other customers. We maintain controls and audits on all marketing materials to ensure they are compliant before publication.
Whether offline or online, all LivaNova collateral materials used for training, education and marketing to assist or inform the promotion of, and education on, LivaNova products or requesting distribution of scientific-medical information for promotional purposes are subject to the Global Collateral Materials Review Procedure. The internal Collateral Review Board is comprised of designees from appropriate departments who have been trained on the review and approval processes for collateral material. In addition, sales and marketing employees receive regular training on our compliance procedures.
We are committed to maintaining the safety and security of our employees, patients, patient data and products. Throughout the entire product lifecycle from design, to manufacturing, to patient use, we work to manufacture the most secure products possible. Our cybersecurity oversight and management are generally based on the National Institute of Standards and Technology and other applicable industry standards. We routinely assess our network vulnerabilities and communicate appropriate mitigations to key stakeholders. All employees, as well as contractors, who have access to our systems, receive at least annual training on cybersecurity and privacy.