Your specialist for building regulatory-compliant SaMD (Software as a Medical Device) and AIaMD (Artificial Intelligence as a Medical Device). Expertise in navigating ISO 13485, IEC 62304, ISO 14971, and IEC 62366-1 With our Dedicated SaMD Quality Management System (QMS) and MDR for the healthcare industry.
Navigating the complex landscape of healthcare regulations for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) can be challenging. Yoctobe simplifies this journey, providing expert development services that ensure compliance with stringent standards like ISO 13485, IEC 62304 and the Medical Device Regulation (MDR). We understand the intricacies of medical device software development and help you bring innovative, safe, and effective solutions to the UK healthcare industry.
Yoctobe's approach to SaMD and AIaMD development is built on a foundation of regulatory expertise and technical excellence, enabling:
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Email: contact@yoctobe.com
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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.
