In line with LivaNova’s mission, the Company develops innovative products that deliver life-changing improvements for patients, and the 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.
One hundred percent of LivaNova 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 US FDA Quality System Regulations for medical devices (21 CFR part 820), 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 the management of the occupational health and safety system.
Products
Quality in Everything We Do
What We Are Doing
Facility Compliance
LivaNova’s Quality Management System
Product Performance
Information Security & Privacy
Information Security & Privacy
LivaNova endeavors to bring the latest technology to all products in a safe and secure manner. In doing so, the Company strives to integrate both privacy and information security into both 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, and that restricts the use and disclosure of this information. LivaNova works to comply with various privacy standards and to adapt its business processes to ensure that the safety of its products and the security of patient information remain at the Company’s core.
LivaNova has dedicated resources and processes to help prevent, detect, and respond to cyber threats. The information security team, led by the Chief Information Security Officer (CISO), manages the Company’s Information Security Management System (ISMS) with the objective of strengthening cyber resiliency. LivaNova’s ISMS strengthening plans consider leading industry standards, such as the National Institute of Standards and Technology (NIST) cybersecurity framework, the ISO 27001 international standard for information security management system standard, the Committee of Sponsoring Organizations of the Treadway Commission (COSO), and other security controls to apply across the business.
