Efficient and safe software and processes
Quality, safety, and performance
For us, quality, safety, and performance are not options but the cornerstones that all our operations are based on.
We strongly believe in our doing and as external proof we have acquired the following certificates:
MDR (EU) 2017/745 Annex IX (I)
ISO 27001 (Information security management systems)
ISO 13485 (quality management for medical devices)
In addition we are naturally cooperating with EU and local authorities and comply with other requirements and legistlation which are required locally.
“Certifications are a way to show that our software and processes are safe and efficient”
MDR (EU) 2017/745 ANNEX IX
BCB Medical’s Disease Specific Register (DSR) software is used for evaluating the effectiveness and quality of care as well as for improving care pathway. The BCB Disease Specific Register has been granted with a product certificate in accordance with the MDR (Medical Device Regulation) Category IIa Regulation (MDR) Regulation of the European Union. The effective date of the certificate is 23 January 2023 and is issued by SGS Fimko Ltd.
MDR is a legislative act that applies to all manufacturers of medical devices. The new certification is a valuable acknowledgment of BCB Medical’s persistent work to improve product effiency patient safety.
If you are interested for more information please Contact Us
ISO/IEC 27001:2013
High security is part of our quality system and an essential part of operations and solution development. With the ISO 27001 certification, BCB Medical proves to be a trusted service provider and partner. The certification ensures that we have documented processes, audited ways of working, risk management and transparency for the company when developing functions even further.
Download a copy of our ISO 27001 certificate here
ISO 13485:2016
ISO 13485 is the most widely used international standard for quality management in medical device industry. BCB Medical has been assessed and certified to meet the requirements of ISO13485:2016, since 2014 for the following activities: design, development, manufacture, distribution, sales, support and maintenance of medical information and register software and services for healthcare.
Download a copy of our ISO 134185 certificate here
