BlueBridge Technologies is a digital medical device software development partner that fully understands the intricacies and complexities of medical device regulations. Our highly experienced team has successfully developed Software as a Medical Device (SaMD) up to Class C safety classification. Our proven project governance process ensures the correct implementation and coordination of your project’s delivery. We do this by efficiently implementing ISO 13485 quality management systems inside of a well-defined and audited IEC 62304 software development life cycle and Risk management ISO 14971.
Navigating the Complex World of Medical Device Regulations
The Perfected The Process
We cover all phases of the product life cycle including – exploratory; design; implementation; maintenance; and post-market surveillance. During these phases we follow the INCOSE 7 steps of success: understand the problem; investigate alternative solutions; define and agree system architecture; agree and manage requirements; agree and manage interfaces; prepare the test and support systems; and track progress against a plan. From Waterfall methods to Agile processes, we harness frameworks that work towards your goal in a way that is flexible enough to adapt to changing requirements, surface potential issues early in the process and pivot when necessary.
Why Companies Choose BlueBridge Technologies
Our experts not only understand the regulation and the application of the regulatory landscape, they use best in class frameworks and tools to successfully deliver your project. We’ve perfected a sophisticated governance structure that allows us to manage large and complex projects that have multiple stakeholders. We use the latest tools and technologies to increase quality and productivity, reduce risk and implementation costs, and improve inter project stakeholder communications and task analysis. But above all else, we ensure we deliver the highest quality outcomes for you.