This is according to Mari Isberg, QA Manager at XVIVO Perfusion AB, which develops and sells technologies to extend the time surgeons have to perform organ transplants. The company has grown at record speed. "When I started in 2019, we had 40 employees. Now, in November 2023, we are 150."
XVIVO is committed to extending the time that all major organs - lung, heart, liver and kidney - can exist ex vivo, i.e. outside the body. This makes more organs available for transplantation and allows them to be transported over longer distances. Their industry-renowned XVIVO Perfusion System (XPS ) is a so-called EVLP platform – Ex Vivo Lung Perfusion – that not only extends the transplant
window for lungs, but also enables the evaluation of lungs that were initially considered too poor to be transplanted.
– We have been the market leader in machine perfusion of lungs for many years and our largest market is in the US. In Sweden, there are two clinics that transplant lungs – Sahlgrenska in Gothenburg and Skåne University Hospital in Lund – and they performed a total of 50 lung transplants in 2022. In many countries, there are only a few clinics," says Mari Isberg.
Standards and regulations
There are many mandatory standards and regulations that an international medtech company like XVIVO must follow. Some countries rely on ISO 13485, while others have their own regulations.
This applies, for example, to the United States, which has strict requirements, particularly in relation to electronic signatures (ES) and electronic records (ER).
The latter has an entire regulatory framework with more requirements than ISO 13485.
– XVIVO meets the Australian, Brazilian, Canadian, American and Chinese regulations for medical devices, among others. And in Europe there are both EU and national regulations that must be met to sell in each country, says Mari, and continues:
– Europe also has a new regulation for medical devices called MDR – Medical Device Regulations – which replaced the MDD in May 2021. In other words, there is quite a bit more than just standards that we must meet.
Document management
XVIVO uses the CANEA Document module for the governing and reporting documents that the management system requires, such as:
- Policies, process descriptions, work instructions and templates.
- Technical product documentation.
- Staff training certificates.
- Supplier evaluations.
- Production documentation.
- Contracts – a new document type under
development that will improve control over all
contracts.
Case/workflow management
XVIVO uses the CANEA Workflow module for:
- Complaints.
- QMS and product deviations – nonconformity (NC) and corrective action and preventive action (CAPA).
- Internal and external audits.
- Suppliers & subcontractors – easily accessible cards with contact details, assessments, certificates, etc.
- Changes to products and changes to the quality management system (QMS).
- Equipment – with full control of calibrations and maintenance of production equipment.
- Clinical studies – Safety Event Handling.
– We also use CANEA Workflow for the product life cycle, i.e. service, maintenance and traceability. This means that we know where all the machines are, what has been done to them and which components have been replaced due to breakage or as part of planned maintenance.
– In other words, we have a workflow for the entire life cycle, including scrapping. Everything we do and think is documented with full traceability in the system.
Audits and reviews
A medtech company is reviewed by customers as well as notified bodies and authorities in each country.
– Our notified body thinks we have a good system where we can quickly find what they are asking for. We had an audit from Chinese authorities the other week and they were very happy with what they saw. And an external party from the Netherlands who did an internal audit thought it looked very good, especially in terms of traceability. They were very satisfied.
– And a good rating is also that we had no deviations in the system itself, the validation or the backups. So, it feels safe, at least so far.
CANEA ONE eQMS
The CANEA ONE quality management system consists of five modules and XVIVO acquired CANEA Document, CANEA Workflow and CANEA Process in 2017. But the company’s existing processes was so well structured that it has not yet wanted to invest the time needed to start using the latter module.
– CANEA ONE is easily accessible, and the information is easy to find, but it depends on how you set up the system. CANEA has laid a very good foundation with a functioning structure, which we have built on. But you must be prepared for regulatory changes. This happened, for example, with the introduction of the MDR. As a small company, we did not want to be so detail-oriented, but this is a need that has changed as we have grown. A system must be able to expand with the company and CANEA ONE has done that," concludes Mari Isberg
”I would give CANEA a score of 4.5 out
of 5 for the delivery and the product..”
Mari Isberg, QA Manager, XVIVO Perfusion AB
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