Products

Quality in Everything We Do

Quality in Everything We Do

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 compliance with all laws, standards and regulations regarding quality, safety and performance.

100% 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 we operate, 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 manufacturing sites in Italy and Germany are ISO 14001 certified, i.e., the international standard for designing and implementing an environmental management system (EMS). The LivaNova manufacturing site in Italy is also certified ISO 45001, the international standard for the management of the occupational health and safety system.

Our Global Impact

 

135,000+ PATIENTS treated with VNS TherapyTM

40,000+ CHILDREN treated with VNS TherapyTM

3.5M+ PATIENTS treated with personalized and proven performance of InspireTM oxygenator

474,000+ NEW PATIENTS treated with InspireTM in 2023

50+ YEARS of perfusion know-how and worldwide leadership with S5TM HLM and EssenzTM HLM

10,000+(1) PATIENTS treated treated with EssenzTM new product released in the last 14 months demonstrating LivaNova’s commitment of transforming patient outcome with innovative products and therapies TM

4M+ PATIENTS treated with Essenz TM Autotransfusion System

8% increase of PATIENTS treated with XtraTM Autotransfusion System in 2023 and receiving autologous blood, reducing use of heterologous blood bank

(1) Calculated based on number of EssenzTM HLM installed and considering 1 procedure/day, 4 days/week.

 

 

What We Are Doing

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Facility Compliance

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LivaNova’s Quality Management System

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medical equipment

Product Performance

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Information Security & Privacy

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Facility Compliance

LivaNova sites undergo audits by regulatory authorities and notified bodies on a regular basis, to verify compliance with the regulations in all geographies where the Company distributes products. This includes regular inspections by the US FDA. No Warning Letter was issued to a LivaNova site within the last 3 years.

US FDA WARNING LETTERS ISSUED

  FY21 FY22 FY23
FDA Warning Letters 0 0 0

 

LivaNova’s Quality Management System

LivaNova’s Quality Management System (QMS) is designed to build quality into products at every stage of the lifecycle, starting from the design and development through manufacturing, testing, distribution, and post-market surveillance.

Employee Training

  • 100% employees responsible for product quality complete training on quality control, product safety and/or QMS. Compliance effectiveness of employee training is monitored and tracked through an electronic training record system.

Supplier Management

  • 100% parts and components not made in-house are sourced from approved suppliers and monitored by LivaNova’s Supplier Quality team. The team is trained to the Company’s rigorous Supplier Quality Process standard which outlines requirements in selecting, qualifying, managing and monitoring suppliers to ensure that all purchased, subcontracted, or otherwise received products and services are controlled and conform to a high-quality standard.
  • More than 90% of identified high risk, direct material and component suppliers have been audited since 2020 to ensure compliance with LivaNova’s QMS and with applicable regulations. Risk level is determined by the Company’s QMS risk assessment process.
  • Ongoing engagement and collaboration on process improvements to further drive innovation, sustainability, and patient safety is prioritized. For example, in 2023, LivaNova engaged 100% of identified high risk, direct material and component suppliers to attend workshops for education on the Company’s QMS and production process controls, providing insight into how supplied materials and components impact the Company’s devices and patients.

Product Performance

As part of LivaNova’s Quality Management System (QMS), the Company’s Corrective and Preventative Actions (CAPA) program embeds a robust process to identify potential issues and to take action to resolve. Additionally, the risk management process follows the ISO 14971 standard for medical devices which ensures the safety and effectiveness of the devices for the intended use.

LivaNova monitors the use and performance of the products distributed to the market through the post market surveillance system by gathering data from customer feedback collected through the Company’s global complaint handling process and via medical and clinical literature review, with information shared and communicated to customers, patients, and internally via the risk management process. Further, when alerted of potential safety concerns in the market, LivaNova takes immediate actions through the embedded QMS correction and removal process.

Product Performance governance is led by cross-functional leaders from LivaNova’s Medical Affairs, Supplier Quality, and Scientific Communication teams, with a quarterly executive team partnership to review product quality risks, set quality targets, and support continuous improvement actions.

US FDA RECALLS INITIATED

  FY21 FY22 FY23
FDA Class I Recalls Initiated 0 2 0
FDA Class II Recalls Initiated 2 0 2
FDA Class III Recalls Initiated 2 0 0

 

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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 products and services. LivaNova is subject to various local and international laws that protect the privacy and confidentiality of certain patient health information, including patient medical records, and that restricts the use and disclosure of patient health information. LivaNova works to comply with various privacy standards and to adapt business processes to ensure that the safety of products and patients’ 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 NIST cybersecurity framework, ISO 27001, COSO, and other security controls to apply across the business.

Other Sustainability Focus Areas

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People

Our employees are crucial in our mission to provide hope and life-changing innovation to our patients and their families.
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Planet

Our environmental commitment runs from product design through manufacturing and end-of-use disposal and recycling.

Corporate Governance

Our Board of Directors and executive leadership team ensure accountability, transparency and fairness throughout the company. Governance practices influence our corporate strategy, business operations, environmental impacts, ethics & integrity, compensation and management of risk. The Board continually considers corporate governance improvements and models a culture of compliance.

Explore Our Governance