From the beginning —
From the beginning getting it right is critical. That’s because little mistakes become big problems down the road.
When lives are at stake, you have to be right. Beginning to end.
When your project needs to be right the first time, Blue Sages is the place to begin. When it comes to the development of life critical systems, Blue Sages starts right and keeps you right. All the way through design, development and release — version after version. We can make this claim because we’re not just ‘software guys’, we’re systems engineers. We are software experts, but we also know hardware and manufacturing. We’re experienced in engineering and development, but we also understand manufacturing and operations. More important, we know design, engineering and manufacturing operations are inherently complex and interdependent. And that means we don’t address a single issue — we make sure solving one problem doesn’t create another down the line. Getting it right from beginning to end and all points in between requires a holistic view as well as an optimized and efficient process. And that requires leadership, experience and expertise in a wide variety of disciplines.
Applied Systems and Product Design Standards
- FDA guidelines
- FDA regulations
- ISO regulations including ISO 13485, ISO 14971