LivaNova’s mission is to “create ingenious medical solutions that ignite patient turnarounds”, and the Company’s approach to quality starts and ends with patient and customer safety. LivaNova is dedicated to complying with all laws, standards, and regulations regarding quality, safety, and performance.
All LivaNova’s manufacturing and R&D facilities are ISO 13485 certified, i.e. the International Organization for Standardization’s quality management system standard for medical devices. LivaNova also complies with all applicable regulations and/or legislations in jurisdictions where it operates, including but not limited to the European medical legislative requirements (Directive 93/42/EEC and Medical Device Regulation 2017/745), the U.S. Food and Drug Administration (FDA) Quality Management System Regulations for medical devices (21 CFR Part 820 (QMSR)), Japan MHLW Ministerial Ordinance No.169, Canadian Medical Device Regulations (SOR/98-282), Brazil ANVISA – RDC No.16/2013, and the Australian Therapeutic Goods (Medical Devices) Regulations 2002 (TGA). In addition, LivaNova’s manufacturing sites in Italy and Germany are certified to the ISO 14001 international standard for designing and implementing an environmental management system (EMS) and the ISO 45001 international standard for occupational health and safety management system.
Products
Quality in Everything We Do
What We Are Doing
Facility
Compliance
LivaNova’s Quality Management System
Product
Performance
Information Security & Privacy
Cybersecurity & Privacy
LivaNova endeavors to bring the latest technology to all products in a safe and secure manner. In doing so, the Company considers both privacy and cybersecurity in its products and services. LivaNova is subject to various local and international laws that protect the privacy and confidentiality of patient health information, including patient medical records, which restrict the use and disclosure of this information. LivaNova complies with various privacy standards and adapts its business processes to ensure that the safety of its products and the security of patient information remain at the Company’s core.
LivaNova employs dedicated resources and processes to help prevent, detect, and respond to cyber threats. The Cybersecurity team, led by the Chief Information Security Officer (CISO), manages the Company’s cyber risk and assurance program with the objective of strengthening cyber resiliency. LivaNova’s cyber risk and assurance program aligns with leading industry standards, such as the National Institute of Standards and Technology (NIST) cybersecurity framework, the ISO 27001 international standard for information security management systems, the Committee of Sponsoring Organizations of the Treadway Commission (COSO), and other security controls to apply the appropriate cybersecurity measures across the business.
