Quality, safety and performance guide how we develop and deliver healthcare data and software solutions. Our certified processes help healthcare professionals, researchers and decision-makers rely on our solutions with confidence in demanding healthcare environments.
Our commitment extends beyond meeting requirements. We continuously invest in quality management, information security, regulatory compliance, and operational excellence to ensure that our solutions are reliable, secure, and fit for purpose in demanding healthcare environments.
Independently Verified Standards
To demonstrate our commitment, we have obtained internationally recognised certifications and regulatory approvals.
BCB Medical’s Disease Specific Register (DSR) software is used to evaluate the effectiveness and quality of care while supporting the continuous improvement of care pathways. The BCB Disease Specific Register, also called as Clinical Information Management System, has been granted a product certificate in accordance with the European Union Medical Device Regulation (MDR) as a Class IIa medical device.
The certificate became effective on 23 January 2023 and was issued by SGS Fimko Ltd. This certification confirms that our quality management system, products, and processes meet the stringent requirements established for medical devices within the European Union.
MDR is a legislative framework that applies to manufacturers of medical devices across Europe. Achieving MDR certification is a significant milestone and reflects BCB Medical’s long-term commitment to product quality, efficiency, regulatory compliance, and patient safety.
If you would like to learn more about our MDR-certified solutions, please Contact Us.
Protecting sensitive healthcare information is fundamental to our business. Information security is an integral part of our quality system and a key consideration in everything from software development to daily operations.
Our ISO/IEC 27001:2022 certification demonstrates that we have established documented processes, audited ways of working, systematic risk management practices, and continuous improvement mechanisms to safeguard information assets.
This internationally recognised certification provides assurance to our customers, partners, and stakeholders that BCB Medical manages information security in a structured and transparent manner and is committed to maintaining the confidentiality, integrity, and availability of data.
ISO 13485 is the leading international standard for quality management systems in the medical device industry. BCB Medical has been certified according to ISO 13485 since 2014.
The certification covers the design, development, manufacture, distribution, sales, support, and maintenance of medical information systems, disease-specific registries, and software services for healthcare organisations.
This certification demonstrates our commitment to maintaining consistent quality throughout the entire lifecycle of our products and services. It provides our customers with confidence that our solutions are developed and maintained according to recognised international best practices for medical devices.
BCB Medical applies the requirements of the EU AI Act and the ISO 23894 guidance for AI risk management to its quality management system. This supports the safe and responsible use of AI in both product development and AI-assisted solutions.
Our approach builds on BCB Medical’s existing MDR-certified quality management system, ISO 13485 medical device quality processes, ISO 14971 risk management practices, and ISO/IEC 27001-certified information security management system.
By integrating AI-specific regulatory requirements and best practices into this established framework, we ensure that AI-related risks are identified, assessed, controlled, and monitored throughout the product lifecycle.
While the AI Act requirements and verification processes continue to evolve, BCB Medical is proactively preparing for the upcoming regulatory requirements. This means that our AI-assisted products and development methods are guided by transparency, AI literacy, risk management, data protection, quality assurance and continuous improvement — helping healthcare organisations benefit from AI in a safe, reliable and compliant way.
Our compliance with the UK’s Data Security and Protection Toolkit (DSPT) demonstrates our commitment to meeting the information governance and data protection requirements expected by the NHS and other healthcare organisations in the United Kingdom.
The DSPT provides assurance that BCB Medical follows recognised standards for handling healthcare data securely and responsibly.
Commitment to Compliance and Continuous Improvement
In addition to our certified management systems, we work closely with European and local authorities and comply with applicable laws, regulations, and industry requirements in all markets where we operate.
Quality, security, and regulatory compliance are not one-time achievements. Through regular audits, risk management, employee training, and continuous improvement activities, we ensure that our solutions continue to meet evolving healthcare needs and regulatory expectations.
Building Trust Through Quality
Healthcare organisations rely on accurate data, secure systems and dependable software. Our certifications independently verify that BCB Medical operates according to recognised international standards for quality, safety and performance.
Certifications are a way to demonstrate that our software, processes and services are safe, reliable and efficient.
Tapani Loikkanen Chief Quality & Regulatory Officer, BCB Medical
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