Patient safety is always paramount at Portavita. At the same time, compliance with all the regulatory and quality requirements is also very important. That is why, several months ago, Portavita collaborated with Medical Device Project B.V. in initiating the ISO 13485: 2003 certification process. Extensive preliminary research has led to the conclusion that the Anticoagulation module is actually the only module considered to be a Medical Device and therefore eligible for certification. The company’s ISO certification demonstrates that Portavita’s processes comply with international quality standards. The Certificate is issued by DEKRA.
Safeguarding the quality of our software has top priority at Portavita. This is evident from the fact that our processes and procedures are fully equipped for this purpose. For example, an extensive test team conducts more than 400 tests on the system each day. We also have a separate Risk Management committee and a specially appointed Quality Manager. We do not only strive to meet the legislative requirements on such a system but also to improve it even further. The ISO certification is a confirmation of our capabilities.
While the other Portavita modules are not considered to be Medical Devices, Portavita treats them as equivalents in ensuring optimal quality.
Do you want to know more about the quality of our software and the ISO certification in particular? Please feel free to contact Aloys Langemeyer, Director Sales, on telephone number +31 (0)6 4211 8861.
*About ISO 13485:2003
ISO 13485:2003 is an international standard related to quality assurance systems for medical devices. The standard can be used by an organisation for the design, development, production, installation and servicing of medical devices.