BCB Medical is one of the first companies in Finland whose software complies the requirements of the European Union’s Medical Device Regulation (MDR). The new certification is a valuable acknowledgment of BCB Medical’s persistent work to improve patient safety.

The certification was granted for BCB Medical’s Disease Specific Register software which is used for evaluating the effectiveness and quality of care as well as for improving care pathways. The certification verifies that a device meets the Medical Devices Regulation’s requirements for medical devices.

The EU’s new regulation has tighter requirements for medical devices and software. It also sets standardized EU-level regulations for the devices, thus improving patient safety. MDR is a legislative act that applies to all manufacturers of medical devices.

BCB Medical is a trailblazer of certification

EU’s Medical Device Regulation entered into application on 26 May 2021. After transitional periods, all medical devices on the market, including devices that entered the market before the new regulation, must follow MDR. BCB Medical is one of the first software companies in Finland to apply for the new certification.

“Although BCB has long previous experience with ISO 13485 certification, there was still much to learn about the MDR process. In hindsight, it was a wise choice to be a pioneer of certification. At this stage, MDR certification allows BCB Medical to stand out from the competition, as all our major clients, for example in hospital IT management, prefer to acquire certified medical software”, says BCB Medical’s Chief Devops Officer Tapani Loikkanen.

Many companies have not previously noticed what changes the EU’s Medical Device Regulation will bring, so BCB Medical has a head start in MDR certification. This will help the company to strengthen its software’s position on the market.

Detailed process is a guarantee of quality

Before the BCB Disease Specific Register software received MDR certification, the company went through a detailed auditing process. To earn the certification, comprehensive process, and device descriptions as well as record documentation with evidence were required from BCB Medical. Based on the documentation, the auditors were able to verify that all processes followed the descriptions and specifications.

The auditing was carried out in two phases. An EU Notified Body assessed BCB’s operation instructions, operations, and documentation created during the company’s operations. In the first phase of auditing, SGS, the Notified Body that carried out the auditing, confirmed that BCB was qualified to participate in the second phase of the audit. After this, the Notified Body examined the technical documentation of Disease Specific Register. In the second phase of the audit, members of the Notified Body assessed conformity of BCB Medical’s operations during an on-site audit at BCB’s facilities.

” The MDR certification process and our own assessment took time, but also confirmed that BCB Medical’s software is top of the class in our field. Certifications are a way to show that our software and processes are safe and efficient. Certifications are also important for us, as they validate our high-quality work”, Loikkanen says.

BCB Medical’s certificates

• ISO 27001 (information security management systems)
• ISO 13485 (quality management for medical devices)
• MDR (EU) 2017/745 Annex IX (I)

Quality, safety, and performance are the cornerstones that all our operations are based on. Read more from our Quality page.