At Warwick Consulting we are committed to guiding clients in creating an agile Software as a Medical Device (SaMD) lifecycle process that seamlessly incorporates all essential design control elements. We understand the importance of flexibility and innovation in software development while adhering to regulatory requirements.
Our expert team brings together the best of both worlds, enabling clients to develop cutting-edge SaMD solutions with a rigorous design control framework.
We embrace agile principles to foster collaboration, adaptability, and iterative development. Our team works closely with clients to implement agile practices, such as Scrum or Kanban, ensuring quick and efficient response to changing project needs and market demands.
While embracing agility, we prioritize the integration of design control elements mandated by regulatory bodies, such as the FDA. Our SaMD lifecycle process covers comprehensive risk management, requirements management, design input, design output, design verification, design validation, and design transfer, ensuring compliance and traceability throughout the development journey.
We recognize that every SaMD project is unique. Our consultants work closely with clients to tailor the SaMD lifecycle process to their specific needs, project complexity, and regulatory landscape. This flexibility allows for optimized development timelines and efficient resource utilization.
Our team employs a risk-based approach to prioritize tasks and allocate resources effectively. By focusing on critical components and potential hazards, we streamline the SaMD lifecycle process and address high-impact areas efficiently.
As we develop the agile SaMD lifecycle process, we continuously ensure alignment with relevant regulatory guidelines and standards, such as IEC 62304 and ISO 14971. This alignment ensures clients stay ahead of regulatory changes and maintain compliance throughout the development journey.
Collaboration is key to successful SaMD development. We facilitate cross-functional communication and collaboration among software engineers, regulatory experts, quality specialists, and stakeholders, fostering a cohesive and synchronized development effort.
Joining forces with Warwick Consulting presents an unwavering alliance within the intricate landscape of Software as a Medical Device (SaMD) assurance. Our unwavering commitment is geared towards steering you through challenges, reinstating software integrity, and strategically aligning your systems for long-lasting success.
Initiate your journey today to uncover your SaMD assurance needs and explore how we can fortify your path towards robust compliance.