Certification process - IEC 62304
Accelerate the certification process and market introduction of your digital medical devices.
We assist healthcare organisations in both developing and certifying digital medical technologies. Our methodology integrates compliance throughout the entire product lifecycle, enabling faster delivery and facilitating more efficient access to the market.
Your main challenges
A complex regulatory framework hindering innovation
The development of digital medical devices requires compliance with rigorous standards, including ISO 13485, IEC 62304, IEC 62366, ISO 14971 and the forthcoming AI Act. While these requirements are vital for ensuring safety, they tend to lengthen validation cycles and prolong the release of product updates.
Scarcity of expertise delaying compliance
Ensuring compliance for health software requires specific expertise in quality management, regulatory affairs, risk management, clinical input and usability. Cultivating these capabilities internally presents a considerable challenge. Without such skills, achieving CE marking or FDA clearance becomes arduous, restricting entry to both European and international markets.
.svg)
Protracted and costly regulatory processes
Establishing a quality management system, structuring compliant operational processes and producing comprehensive documentation all demand substantial investment. Even for a single application, these efforts can span several years, creating significant tension between regulatory requirements and the economic viability of innovation.
Our approach
Embedding continuous compliance within development
Our Continuous Compliance Delivery approach unites expertise in product design, software engineering and regulatory affairs. Drawing inspiration from DevOps methodologies, this framework enables frequent software releases while maintaining full compliance with all applicable healthcare standards.
Automating traceability to streamline compliance
Each regulatory requirement is systematically integrated into the codebase; every development ticket serves as documented evidence and every test is automatically traced and kept up to date. This approach ensures ongoing compliance while reducing the complexity and cost of regulatory oversight.
Accelerating documentation and testing through artificial intelligence
Our proprietary AI agents significantly expedite the processes of specification writing, risk management and verification testing. This carefully controlled automation reduces the time required for these activities by up to 20 times, without compromising comprehensive human oversight.
Comprehensive support from scoping to CE marking
We provide continuous support throughout every phase of your project, from initial scoping and development through to thorough documentation and final certification. Week by week, we help advance your product towards market readiness, ensuring seamless alignment between engineering activities and regulatory requirements.
.svg)
.svg)
