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.