Our quality goal is to optimise the effectiveness and efficiency of the medical process for both patients and medical professionals, while complying with relevant regulations and (international) standards. The following facts support our progress in this respect:
- We are compliant with the European medical device directive 93/42/EEC (CE label)
- We are compliant with the COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices
- Portavita complies with the Dutch and German Personal Data Protection Acts, and protects the privacy of its customers and contacts at all times
- Portavita is certified to ISO 13485:2003 by Dekra
- Portavita has the Zelfzorg Ondersteund label (ZO!)
- Portavita has a Security and Data Privacy Officer and a Quality & Compliance Manager
- Portavita has a Scientific Council with external members
- Portavita has a Risk Management Committee Portavita (RMCP) with external members
- Portavita has a successful track record of many years as a Software Service solution for patient self-management
- The high availability of our system is guaranteed by the redundancy that we have implemented in our system configuration
Portavita is certified to the ISO 13485:2003 since 22 January 2014. This ISO 13485:2003 certification is an important reassurance to our customers and patients, ensuring that we continuously set high quality standards for our products
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, in 2013, 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 strive not only 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.
*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.
The Portavita Anticoagulation module, being classified as a medical device, is CE marked
CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of the European Medical Device Directive and is a legal requirement for placing a device on the market in the European Union.
1018 MR Amsterdam
hereby certifies that the
Portavita Anticoagulation application, a medical device to support patients and thrombosis services in determining the dose of anticoagulation medication in the therapeutic framework,
complies with the requirements of European Directive 93/42/EEC concerning medical devices.
Registration number: NL-CA001-2010-3008122
E.J. Hoijtink, General Manager
Amsterdam, January 2011
Due to the ever-increasing use of the software by both patients and care workers, Portavita has taken a new step in strengthening its quality assurance with the creation of the Risk Management Committee Portavita (RMCP) in February 2011.
The RMCP has been set up to frame risks as much as possible, and therefore has the following tasks :
- Towards employees: monitoring the risk management by the employees, by ensuring that they are aware of the risks, that they do everything to avoid it such risks, and that they take quick action in the event of failure;
- Towards management: annual stocktaking, analysis and reporting of new emerging risks, and providing advice on dealing with risks;
- Towards the world outside: making sure that Portavita can justify how it deals with risks;
- Taking action in the event of urgent risks.
The members of the RMCP come from both inside and outside Portavita:
- Drs. Edo Westerhuis, COO Portavita (Chairman)
- Prof. Mark Kramer, Head of Internal Medicine VUMC, member American Society of Hematology (external member)
- Hein Willem de Bruijn, Account Manager Portavita
- Jan Willem Kijne, Information Security and Project Manager Portavita
- Ir. Olivier Marchesini, Quality and Compliance Manager Portavita
- Jos Verhagen, Developer, Risk Management Development
The mission of the Scientific Council Portavita (SCP) is to support Portavita in the scientific foundation underlying its products and activities.
The Scientific Council performs the following tasks:
- The SCP monitors the scientific quality of the medical devices and medical software
- The SCP validates the charters of the medical committees
- The SCP oversees the medical validation of the products and changes done in the medical committees
- The SCP gives advice on changes in the medical devices and medical software
- The SCP validates the post-market analysis of the medical devices and medical software
- The SCP notifies the Managing Board of medical developments in the markets of Portavita
- The SCP is Portavita’s ambassador to scientific associations
- The SCP may advise the Managing Board on product development
- The SCP can be asked to support the participation of Portavita in scientific research projects
- The SCP reports to the Managing Board once a year regarding the scientific developments
Members of the Scientific Council Portavita in 2014 are:
- Chairman: Dr M.J. Beinema – MD PhD, Head physician at Thrombosis Centre Deventer Hospital, Winterswijk hospital, Doetinchem hospital
- Vice Chairman: Edo Westerhuis, COO Portavita
- Secretary: Olivier Marchesini, Quality and Compliance Manager Portavita
- Member: Hein Willem de Bruijn, Anticoagulation Product Specialist Portavita