Systems Engineering
Our systems engineering team plays a key role in every design project, starting with the development of product requirements to satisfy customer needs and the intended use. As the architects of the medical devices and instruments that we design, our systems engineers also ensure that all subassemblies integrate seamlessly to smooth the transition of your device from development to production.
This team has the critical responsibility of verifying that product designs meet all specified requirements. Systems engineering manages and documents appropriate technical reviews, risk management activities, and testing, and maintains the product design history file, which are essential ingredients for traceability and regulatory compliance.
Our strength is in our experience. Our systems engineers have a wealth of cross-functional expertise, allowing us to create manufacturable and regulatory-friendly designs. In particular, we have competencies in:
Additional areas of expertise