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 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 patient safety.
As a part of becoming MDR ready, 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 new and existing regulations.
ISO13485 has built-in mechanisms that allow for traceability of devices. In addition, we have implemented procedures for the recall of faulty products and for market surveillance, which ensures the continued monitoring of medical devises and their performance.
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 becoming MDR ready, all technical documentation has been updated from MDD requirements to the new stricter MDR requirements. The products are still the same, but the documentation has been strengthened.
You will be able to recognize medical devices based on the new MD logo. In addition, all medical devices have been updated with new bar codes that ensure enhanced traceability.