Yoctobe delivers custom healthcare software development solutions for regulatory-compliant SaMD (Software as a Medical Device) and AIaMD (Artificial Intelligence as a Medical Device). We provide expert guidance on ISO 13485, IEC 62304, ISO 14971, and IEC 62366-1, backed by our dedicated SaMD Quality Management System (QMS) and compliance with MDR to ensure safe, reliable, and market-ready healthcare software.
Navigating healthcare regulations for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) can be complex. Yoctobe simplifies this process with expert custom healthcare software development, ensuring compliance with standards such as ISO 13485, IEC 62304, and the Medical Device Regulation (MDR). We help you deliver innovative, safe, and effective medical software solutions to the UK healthcare industry with confidence.
Yoctobe's approach to healthcare software and SaMD/AIaMD development in particular is built on a foundation of regulatory expertise and technical excellence, enabling:
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Our team possesses in-depth knowledge of the UK and European regulatory frameworks, including IEC 62304, EN IEC 62304, and the Europe Medical Device Regulation (MDR). We translate these requirements into practical development strategies.
From initial concept and risk assessment to design, development, testing, and post-market surveillance, we provide expert support throughout the entire lifecycle of your medical device software.
We embed medical device quality management system principles into our development processes, ensuring the highest standards of safety, reliability, and performance for your software for medical applications.
Security and seamless integration are paramount. We develop solutions with robust security measures to protect patient data and ensure interoperability with existing healthcare IT infrastructure.
Recognizing the unique challenges of AIaMD development, our team offers specialized expertise in areas like algorithm validation, bias detection, and explainability to ensure regulatory compliance and clinical acceptance.
We maintain meticulous documentation and traceability throughout the medical device software development process, facilitating regulatory submissions and audits.
At Yoctobe, we understand that compliance is not just a requirement; it's fundamental to building trust in your SaMD and AIaMD solutions within the healthcare industry. Our commitment is to provide you with the expertise and support needed to navigate the regulatory landscape with confidence.
