Compliant SaMD & AIaMD Development

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.

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Your Trusted Partner for Regulatory-Compliant SaMD & AIaMD Development in the UK

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.

The Foundation of Compliant Medical Device Software

Yoctobe's approach to SaMD and AIaMD development is built on a foundation of regulatory expertise and technical excellence, enabling:

  • Development of medical device software that meets the highest safety and performance standards.
  • Seamless integration of your SaMD and AIaMD with existing healthcare systems.
  • Expertise in navigating the requirements of ISO 13485, IEC 62304 and other relevant regulations.
  • A focus on building robust and reliable software for medical applications.

CONTACT

Phone: +44 773 73 403 49
Email: contact@yoctobe.com

Technical support
24/7

Key Capabilities in Compliant SaMD & AIaMD Development

Deep Regulatory Insight

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.

End-to-End Development Lifecycle Management

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.

Quality-Driven Approach

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.

Secure and Interoperable Solutions

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.

Specialized AIaMD Expertise

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.

Comprehensive Documentation and Traceability

We maintain meticulous documentation and traceability throughout the medical device software development process, facilitating regulatory submissions and audits.

Data Integration Flows

Ensuring Compliance and Quality: Our Commitment to Your Success

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.

  • Navigating the Regulatory Maze: We act as your guide through the complexities of IEC 62304, EN IEC 62304, and the Europe Medical Device Regulation (MDR), providing clear and actionable advice.
  • Building a Strong Foundation for Quality: We help you establish and maintain a robust medical device quality management system, ensuring that quality is embedded in every aspect of your medical device software development.
  • Focus on Patient Safety and Data Protection: Our development practices prioritize patient safety and the secure handling of sensitive health information in accordance with regulations like GDPR and relevant UK data protection laws.
  • Partnering for Long-Term Compliance: We provide ongoing support for post-market surveillance and updates to ensure your software as medical device and artificial intelligence as a medical device remain compliant throughout their lifecycle.