Patient safety is nothing new for ABENA. Because we care, patient safety has been an integrated part of ABENA’s culture in the nearly 50 years we have been working in the health care sector.
We have worked actively with MDD since its implementation in 1993, and stepped into MDR in 2021. Thanks to our years of experience with documentation and from sourcing the world, you can trust that our products live up to all relevant legislation and regulation.
But it’s not enough to care about patient safety. Stringent processes and systems must be in place that ensure best practice is followed throughout the organization. MDR enables the best possible framework for user safety.
Quality assurance
As a part of complying with MDR, ABENA has upgraded our quality assurance system to ISO13485.
An essential part of MDR is to have a strong quality assurance system. ABENA has gone through internal procedures and requirements for documentation and quality assurance to ensure that products live up to all existing regulations.
ABOUT ISO13485
ISO13485 is an internationally acknowledged standard for quality assurance of medical devices.
ISO13485 has built-in mechanisms that allow for traceability of devices. ISO13485 has been harmonized to MDR, so by being ISO13485 certified ABENA comply to quality assurance requirements set out by MDR.
In addition, we have updated procedures for the recall of faulty products and for market surveillance, which ensures the continued monitoring of medical devises and their performance.
Technical Documentation ensures safety first
The scope of MDR is safety first. This safety must also be demonstrated in the technical documentation of all medical devices. As a part of complying with MDR ready, we updated all technical documentation from MDD requirements to the stricter MDR requirements. The products are still the same, but the documentation is strengthened. Note, that you are always able to recognize medical devices based on the MD logo.
Read more about Quality at ABENA
At ABENA, quality is key. Emphasis on the highest quality in our processes, workflows, own production, and products are crucial to us.
