Quality & Regulatory Excellence: It's in Our DNA
At BDS, we understand that regulatory compliance is critical for our customers. It’s not just about meeting requirements; it’s about ensuring patient safety and maintaining the highest standards of quality. That’s why we’ve built a culture of compliance into everything we do. It’s in our DNA.
Patient safety drives our commitment to our Quality Management System (QMS). Quality has many aspects at BDS, and our QMS is just one of them. Our other focus areas include code quality, quality products, usability engineering, and continuous improvement.
Certifications & Standards
BDS is audited, certified and accredited against the following standards:
- ISO 13485:2016: Medical Devices – Quality Management Systems – Requirements For Regulatory Purposes
- MDSAP: Medical Device Single Audit Programme, which includes regulatory requirements for USA, Brazil, Australia, Japan and Canada
- ISO 27001:2022: Information Security, cybersecurity and privacy protection – Information Security Management Systems – Requirements
- Cyber Essentials: UK government-backed cybersecurity certification scheme
- BS EN 62304:2006 + A1:2015: Medical Device Software – Software Life Cycle Processes
- ISO 14971:2019: Medical Devices – Application of Risk Management to Medical Devices
- ISO 15223-1:2021: Medical Devices – Symbols to be used with information to be supplied by the manufacturer
- BS EN 62366-1:2015: Medical Devices – Application of Usability Engineering to Medical Devices
Our team has extensive experience with direct and supporting submissions across multiple regulatory jurisdictions:
- United States: FDA 510(k) submissions and compliance with CFR Title 21 Part 820
- European Union: EU IVDR 2017/746 compliance via our Authorised Representative in Malta
- United Kingdom: MHRA compliance under UK Medical Devices Regulations 2002
- Australia: TGA registration (performed via business partner submissions)
- Canada: Health Canada registration (performed via business partner submissions)
- Saudi Arabia: Saudi FDA registration (performed via business partner submissions)
- China: NMPA registration (performed via business partner submissions)
- Switzerland: Registration performed via Authorised Representative
- Brazil: ANVISA registration (performed via business partner submissions)
Quality Management Approach
Information Security & Cybersecurity
Information security at BDS starts from the ground up. We go above and beyond what is expected from our ISO 27001 obligations by investing in industry-leading, AI-enhanced EDR/XDR security platforms, cloud-based email security and next-generation firewalling.
- Risk-Based Security: Cybersecurity is introduced into the development lifecycle from the beginning, with analysis of product requirements to identify security constraints
- Threat Modelling: Proposed architectures are threat-modeled to identify weaknesses, with iterative improvements until the architecture is secure
- Secure Development: Code undergoes Static Application Security Testing (SAST) and Software Composition Analysis (SCA) during development
- Penetration Testing: Deployable products are submitted for automated penetration testing to identify vulnerabilities
- Multi-Layered Protection: We employ multi-layered patching and update strategies, regardless of system location
- Proactive Monitoring: We proactively check our products and infrastructure against penetration testing platforms to ensure weaknesses are spotted and resolved quickly
We believe in taking pre-emptive measures to stay ahead of current threats and to keep information safe. Above all, these measures are built upon robust BDS processes and practises to ensure that information is accurate and protected at all stages of its lifecycle.
Value Proposition
Our comprehensive quality and regulatory approach delivers:
- Deep Industry Expertise: Insights gained through our wide range of partnerships ensure high congruence with operational targets
- Custom-Tailored Deployment: Foundational software products enhanced and customized to meet stringent requirements
- Extensive Middleware Experience: Over 5,000 middleware solutions placed globally, demonstrating our technology’s reliability
- Pooling Proficiency: 510(k) clearance for pooling result management with proven success across various pooling environments
- Scalable Technologies: Cloud and container-based products developed specifically for healthcare software applications
- Regulatory Excellence: Comprehensive PMS strategies and advanced understanding of regulatory processes
We believe that compliance is not just a box to check; it’s an integral part of delivering high-quality solutions that our customers can trust. It’s in our DNA to support your compliance efforts, giving you the confidence to focus on what matters most: improving patient care.